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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05969236




Registration number
NCT05969236
Ethics application status
Date submitted
24/07/2023
Date registered
1/08/2023

Titles & IDs
Public title
A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults
Scientific title
A Phase 1, First-in-Human, Single-center, Randomized, Double-masked, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of MDI-1228_mesylate Ophthalmic Solution by Local Instillation in Adult Healthy Volunteers
Secondary ID [1] 0 0
MDI-1228-I-AC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Conjunctivitis 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MDI-1228_mesylate Ophthalmic Solution
Treatment: Drugs - Placebo

Experimental: Experimental Group - Including 2 single dose groups (Part A) and 2 multiple dose groups (Part B). Participants in experimental groups will receive MDI-1228_mesylate Ophthalmic Solution.

Placebo comparator: Comparator Group - One comparator group will be set for each of the 4 experimental groups, to a total of 4 comparator groups. Participants in comparator groups will receive placebo.


Treatment: Drugs: MDI-1228_mesylate Ophthalmic Solution
MDI-1228_mesylate Ophthalmic Solution includes 2 strengths:

* 0.1% (0.4 mL \[0.4 mg\] free base)
* 0.3% (0.4 mL \[1.2 mg\] free base)

Treatment: Drugs: Placebo
The components employed in the placebo formulation are the same as those used for the active formulation except MDI-1228_mesylate is absent.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and B - Incidence and severity of all systemic or ocular treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
From first dose to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [2] 0 0
Part A and B - Assessment of vital sign measurement results - respiratory rate
Timepoint [2] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [3] 0 0
Part A and B - Assessment of vital sign measurement results - heart rate
Timepoint [3] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [4] 0 0
Part A and B - Assessment of vital sign measurement results - blood pressure
Timepoint [4] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [5] 0 0
Part A and B - Assessment of vital sign measurement results - body temperature
Timepoint [5] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [6] 0 0
Part A and B - Assessment of physical examination results - general appearance
Timepoint [6] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [7] 0 0
Part A and B - Assessment of physical examination results - head, eyes, ears, nose, and throat (HEENT)
Timepoint [7] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [8] 0 0
Part A and B - Assessment of physical examination results - neck (including thyroid and nodes)
Timepoint [8] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [9] 0 0
Part A and B - Assessment of physical examination results - cardiovascular system
Timepoint [9] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [10] 0 0
Part A and B - Assessment of physical examination results - respiratory system
Timepoint [10] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [11] 0 0
Part A and B - Assessment of physical examination results - gastrointestinal system
Timepoint [11] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [12] 0 0
Part A and B - Assessment of physical examination results - renal system
Timepoint [12] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [13] 0 0
Part A and B - Assessment of physical examination results - neurological system
Timepoint [13] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [14] 0 0
Part A and B - Assessment of physical examination results - musculoskeletal system
Timepoint [14] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [15] 0 0
Part A and B - Assessment of physical examination results - skin
Timepoint [15] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [16] 0 0
Part A and B - Assessment of 12-lead electrocardiogram (ECG) results - heart rate
Timepoint [16] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [17] 0 0
Part A and B - Assessment of 12-lead ECG results - PR interval
Timepoint [17] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [18] 0 0
Part A and B - Assessment of 12-lead ECG results - QRSD interval
Timepoint [18] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [19] 0 0
Part A and B - Assessment of 12-lead ECG results - QT interval corrected with Fridericia Formula (QTcF)
Timepoint [19] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [20] 0 0
Part A and B - Assessment of 12-lead ECG results - RR interval
Timepoint [20] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [21] 0 0
Part A and B - Ophthalmic assessment - corrected visual acuity (CVA)
Timepoint [21] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [22] 0 0
Part A and B - Ophthalmic assessment - intraocular pressure
Timepoint [22] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [23] 0 0
Part A and B - Ophthalmic assessment - light response pupil test
Timepoint [23] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [24] 0 0
Part A and B - Ophthalmic assessment - extraocular movement test
Timepoint [24] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [25] 0 0
Part A and B - Ophthalmic assessment - slit-lamp examination
Timepoint [25] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [26] 0 0
Part A and B - Ophthalmic assessment - corneal fluorescein staining test
Timepoint [26] 0 0
From screening to end of study (EOS, Day 7±1 day in Part A, Day 14±1 day in Part B)
Primary outcome [27] 0 0
Part A and B - Ophthalmic assessment - dilated fundus examination
Timepoint [27] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [28] 0 0
Part A and B - Assessment of hematology results - red blood cell distribution width
Timepoint [28] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [29] 0 0
Part A and B - Assessment of hematology results - hemoglobin
Timepoint [29] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [30] 0 0
Part A and B - Assessment of hematology results - hematocrit
Timepoint [30] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [31] 0 0
Part A and B - Assessment of hematology results - red blood cell count
Timepoint [31] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [32] 0 0
Part A and B - Assessment of hematology results - white blood cell count
Timepoint [32] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [33] 0 0
Part A and B - Assessment of hematology results - absolute neutrophil count
Timepoint [33] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [34] 0 0
Part A and B - Assessment of hematology results - neutrophil percentage
Timepoint [34] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [35] 0 0
Part A and B - Assessment of hematology results - absolute lymphocyte count
Timepoint [35] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [36] 0 0
Part A and B - Assessment of hematology results - lymphocyte percentage
Timepoint [36] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [37] 0 0
Part A and B - Assessment of hematology results - absolute monocyte count
Timepoint [37] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [38] 0 0
Part A and B - Assessment of hematology results - monocyte percentage
Timepoint [38] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [39] 0 0
Part A and B - Assessment of hematology results - absolute basophil count
Timepoint [39] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [40] 0 0
Part A and B - Assessment of hematology results - basophil percentage
Timepoint [40] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [41] 0 0
Part A and B - Assessment of hematology results - absolute eosinophil count
Timepoint [41] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [42] 0 0
Part A and B - Assessment of hematology results - eosinophil percentage
Timepoint [42] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [43] 0 0
Part A and B - Assessment of hematology results - platelet count
Timepoint [43] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [44] 0 0
Part A and B - Assessment of hematology results - mean cell hemoglobin
Timepoint [44] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [45] 0 0
Part A and B - Assessment of hematology results - mean cell volume
Timepoint [45] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [46] 0 0
Part A and B - Assessment of hematology results - mean cell hemoglobin concentration
Timepoint [46] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [47] 0 0
Part A and B - Assessment of hematology results - mean platelet volume
Timepoint [47] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [48] 0 0
Part A and B - Assessment of coagulation results - international normalized ratio (INR)
Timepoint [48] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [49] 0 0
Part A and B - Assessment of coagulation results - activated partial thromboplastin time (aPTT)
Timepoint [49] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [50] 0 0
Part A and B - Assessment of coagulation results - prothrombin time (PT)
Timepoint [50] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [51] 0 0
Part A and B - Assessment of blood biochemistry results - sodium
Timepoint [51] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [52] 0 0
Part A and B - Assessment of blood biochemistry results - potassium
Timepoint [52] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [53] 0 0
Part A and B - Assessment of blood biochemistry results - chloride
Timepoint [53] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [54] 0 0
Part A and B - Assessment of blood biochemistry results - calcium
Timepoint [54] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [55] 0 0
Part A and B - Assessment of blood biochemistry results - bicarbonate
Timepoint [55] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [56] 0 0
Part A and B - Assessment of blood biochemistry results - albumin
Timepoint [56] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [57] 0 0
Part A and B - Assessment of blood biochemistry results - total protein
Timepoint [57] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [58] 0 0
Part A and B - Assessment of blood biochemistry results - creatinine
Timepoint [58] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [59] 0 0
Part A and B - Assessment of blood biochemistry results - creatine kinase
Timepoint [59] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [60] 0 0
Part A and B - Assessment of blood biochemistry results - estimated glomerular filtration rate (GFR)
Timepoint [60] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [61] 0 0
Part A and B - Assessment of blood biochemistry results - urea
Timepoint [61] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [62] 0 0
Part A and B - Assessment of blood biochemistry results - aspartate aminotransferase (AST)
Timepoint [62] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [63] 0 0
Part A and B - Assessment of blood biochemistry results - alanine aminotransferase (ALT)
Timepoint [63] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [64] 0 0
Part A and B - Assessment of blood biochemistry results - gamma glutamyl transpeptidase (GGT)
Timepoint [64] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [65] 0 0
Part A and B - Assessment of blood biochemistry results - alkaline phosphatase (ALP)
Timepoint [65] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [66] 0 0
Part A and B - Assessment of blood biochemistry results - phosphate
Timepoint [66] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [67] 0 0
Part A and B - Assessment of blood biochemistry results - total bilirubin
Timepoint [67] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [68] 0 0
Part A and B - Assessment of blood biochemistry results - direct bilirubin
Timepoint [68] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [69] 0 0
Part A and B - Assessment of blood biochemistry results - indirect bilirubin
Timepoint [69] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [70] 0 0
Part A and B - Assessment of blood biochemistry results - amylase
Timepoint [70] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [71] 0 0
Part A and B - Assessment of blood biochemistry results - cholesterol
Timepoint [71] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [72] 0 0
Part A and B - Assessment of blood biochemistry results - high density lipoprotein (HDL)/cholesterol ratio
Timepoint [72] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [73] 0 0
Part A and B - Assessment of blood biochemistry results - high density lipoprotein (HDL) cholesterol
Timepoint [73] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [74] 0 0
Part A and B - Assessment of blood biochemistry results - low density lipoprotein (LDL) cholesterol/high density lipoprotein (HDL) cholesterol ratio
Timepoint [74] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [75] 0 0
Part A and B - Assessment of blood biochemistry results - low density lipoprotein (LDL) cholesterol
Timepoint [75] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [76] 0 0
Part A and B - Assessment of blood biochemistry results - non-high density lipoprotein (HDL) cholesterol
Timepoint [76] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [77] 0 0
Part A and B - Assessment of blood biochemistry results - triglycerides
Timepoint [77] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [78] 0 0
Part A and B - Assessment of blood biochemistry results - uric acid
Timepoint [78] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [79] 0 0
Part A and B - Assessment of blood biochemistry results - lactate dehydrogenase
Timepoint [79] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [80] 0 0
Part A and B - Assessment of blood biochemistry results - magnesium
Timepoint [80] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [81] 0 0
Part A and B - Assessment of blood biochemistry results - glucose
Timepoint [81] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [82] 0 0
Part A and B - Assessment of blood biochemistry results - anion gap
Timepoint [82] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [83] 0 0
Part A and B - Assessment of blood biochemistry results - adjusted calcium
Timepoint [83] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [84] 0 0
Part A and B - Assessment of blood biochemistry results - globulin
Timepoint [84] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [85] 0 0
Part A and B - Assessment of urinalysis results - pH
Timepoint [85] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [86] 0 0
Part A and B - Assessment of urinalysis results - specific gravity
Timepoint [86] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [87] 0 0
Part A and B - Assessment of urinalysis results - urine glucose
Timepoint [87] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [88] 0 0
Part A and B - Assessment of urinalysis results - urine protein
Timepoint [88] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [89] 0 0
Part A and B - Assessment of urinalysis results - urine bilirubin
Timepoint [89] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [90] 0 0
Part A and B - Assessment of urinalysis results - urine ketones
Timepoint [90] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [91] 0 0
Part A and B - Assessment of urinalysis results - urine blood
Timepoint [91] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [92] 0 0
Part A and B - Assessment of urinalysis results - urine nitrite
Timepoint [92] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [93] 0 0
Part A and B - Assessment of urinalysis results - urine urobilinogen
Timepoint [93] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [94] 0 0
Part A and B - Assessment of urinalysis results - leucocyte esterase
Timepoint [94] 0 0
From screening to end of treatment (Day 2 in Part A, Day 8 in Part B)
Primary outcome [95] 0 0
Part A and B - Assessment of scores of conjunctival hyperemia
Timepoint [95] 0 0
From pre-dose to post-dose (Day 2 in Part A, Day 8 in Part B)
Primary outcome [96] 0 0
Part A and B - Assessment of scores of corneal staining
Timepoint [96] 0 0
From pre-dose to post-dose (Day 2 in Part A, Day 8 in Part B)
Secondary outcome [1] 0 0
Part A - Maximum concentration (Cmax) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution
Timepoint [1] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day)
Secondary outcome [2] 0 0
Part A and B - Time to maximum concentration (Tmax) of MDI-1228_mesylate Ophthalmic Solution
Timepoint [2] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day in Part A, Day 14±1 day in Part B)
Secondary outcome [3] 0 0
Part A and B - Half-life (T1/2) of MDI-1228_mesylate Ophthalmic Solution
Timepoint [3] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day in Part A, Day 14±1 day in Part B)
Secondary outcome [4] 0 0
Part A - Systemic clearance (CL or CL/F) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution
Timepoint [4] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day)
Secondary outcome [5] 0 0
Part A - Volume of distribution (Vd) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution
Timepoint [5] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day)
Secondary outcome [6] 0 0
Part A - Mean retention time (MRT) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution
Timepoint [6] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day)
Secondary outcome [7] 0 0
Part A - Area under curve until time t (AUC0-t) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution
Timepoint [7] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day)
Secondary outcome [8] 0 0
Part A - Area under curve until infinity (AUC0-8) of MDI-1228_mesylate Ophthalmic Solution after a single dose of MDI-1228_mesylate Ophthalmic Solution
Timepoint [8] 0 0
Post-first dose on Day 1 to EOS (Day 7±1 day)
Secondary outcome [9] 0 0
Part B - Trough concentration at steady state (Css_min) of MDI-1228_mesylate Ophthalmic Solution following multiple doses of MDI-1228_mesylate Ophthalmic Solution
Timepoint [9] 0 0
Post-first dose on Day 1 to EOS (Day 14±1 day)
Secondary outcome [10] 0 0
Part B - Maximum plasma concentration at steady state (Css_max) of MDI-1228_mesylate Ophthalmic Solution following multiple doses of MDI-1228_mesylate Ophthalmic Solution
Timepoint [10] 0 0
Post-first dose on Day 1 to EOS (Day 14±1 day)
Secondary outcome [11] 0 0
Part B - Average plasma concentration at steady state (Css_av) of MDI-1228_mesylate Ophthalmic Solution following multiple doses of MDI-1228_mesylate Ophthalmic Solution
Timepoint [11] 0 0
Post-first dose on Day 1 to EOS (Day 14±1 day)
Secondary outcome [12] 0 0
Part B - Clearance (CL or CL/F) of MDI-1228_mesylate Ophthalmic Solution following multiple doses of MDI-1228_mesylate Ophthalmic Solution
Timepoint [12] 0 0
Post-first dose on Day 1 to EOS (Day 14±1 day)
Secondary outcome [13] 0 0
Part B - Area under the plasma concentration-time curve at steady state (AUCss) of MDI-1228_mesylate Ophthalmic Solution following multiple doses of MDI-1228_mesylate Ophthalmic Solution
Timepoint [13] 0 0
Post-first dose on Day 1 to EOS (Day 14±1 day)
Secondary outcome [14] 0 0
Part B - Coefficient of fluctuation (DF) of MDI-1228_mesylate Ophthalmic Solution following multiple doses of MDI-1228_mesylate Ophthalmic Solution
Timepoint [14] 0 0
Post-first dose on Day 1 to EOS (Day 14±1 day)

Eligibility
Key inclusion criteria
1. Weight = 50 kg for males, = 45 kg for females, with the BMI (BMI = weight[kg]/height[m]2) between 18 and 32 (inclusive) at screening.
2. The corrected visual acuity (CVA) of both eyes should be 6/6 or 20/20 (Snellen chart), with an intraocular pressure between 10 and 21 mmHg (inclusive) and a difference in intraocular pressure between the 2 eyes < 5 mmHg at screening.
3. Normal vital signs after = 5 minutes resting supine or semi supine position:

1. = 90 mmHg and =160 mmHg (systolic blood pressure)
2. =50 mmHg and = 95 mmHg (diastolic blood pressure)
3. = 45 beats per minute (bpm) and = 100 bpm (heart rate)
4. Body temperature =35.5? and =37.7?
5. Respiratory Rate=12 breaths/minute and=22 breaths/minute
4. Standard 12-lead ECG parameters after =5 minutes resting in supine or semi-supine position with PR = 120 ms and = 220 ms, QRSD < 120 ms, QTcF = 450 ms for males and = 470 ms for females, and otherwise normal ECG (all data limits are based on average readings of the ECGs) at screening.
5. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or use highly effective contraceptive method as assessed by the PI (OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring or an IUD) from screening until study completion, including the follow up period for at least 30 days after the last dose of study drug, or be post-menopausal for = 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels at screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle will also be eligible for participation.
6. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and admission and be willing to have additional pregnancy tests as required throughout the study.
7. Males must be surgically sterile (> 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method as assessed by the PI from screening until study completion, including the follow up period, for at least 30 days after the last dose of study drug. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long- acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse as part of their usual lifestyle and are not planning to conceive will also be eligible.
8. Male participants must agree to refrain from donating sperm and female participants from donating ova from screening until study completion, including the follow up period, for at least 90 days after the last dose of study drug.
9. Provides written informed consent and is willing and able to undergo all study procedures and attend the scheduled follow up visit/s per protocol.
10. Are willing to consume clinical research unit (CRU) provided meals.
11. Have no neck or back issues which prevents the participant having their head tilted back for dosing at the discretion of the Investigator.
12. Males and females aged 18 to 55 years old (inclusive)
13. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, safety laboratory tests, and ECG. A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. The Investigator may discuss with the local MM and Sponsor MM as required.
14. Have no abnormal results or abnormal not clinically significant (as determined by the Investigator) results of ocular examinations of both eyes (including slit-lamp examination, corneal fluorescein staining test, light response pupil test, extraocular movement test, dilated fundus examination)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have a current or past history of clinically significant circulatory system diseases, respiratory disorders, hepatobiliary disorders, digestive disorders, urinary system diseases, renal disorders, endocrine disorders, immune system disorders, malignancies, metabolic disorders, mental disorders, or nervous system diseases that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the participant by virtue of their participation in the study. Participant with a history of uncomplicated kidney stones (defined as spontaneous passage and no recurrence in the last 5 years); uncomplicated cholecystectomy; Gilbert's syndrome; a past history of being treated by non-current depression may be enrolled in the study at the discretion of the Investigator. Participants with a history of childhood asthma (without hospitalization) that has symptomatically resolved and remains untreated may participant.
2. Have healed eye disorders (such as infection, trauma) in either eye within 1 month prior to the first dose.
3. Have a history of intraocular surgery and laser eye surgery in either eye.
4. Used any ocular products (including various eye drops or eye gel) within 14 days or 5 half-lives (whichever is longer) prior to screening.
5. Wore contact lenses within 2 days prior to baseline (Day -1) or need to wear contact lenses throughout the clinical study.
6. Current evidence or history of COVID-19 or influenza-like illness as defined by fever (> 37.7°C) and 2 or more of the following symptoms within 7 days before dosing: cough, sore throat, runny nose, sneezing, limb/joint pain, headache, vomiting/diarrhea in the absence of a known cause, other than influenza or COVID-19 infection.
7. A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
8. Participants who are intolerant of venipuncture blood collection or have poor venous access and/or have a history of fear of needles and hemophobia.
9. Used Janus kinase (JAK) inhibitors or immunosuppressants or any other prescription drugs, traditional Chinese medicines or Chinese patent medicines within 4 weeks prior to Day -1; or used over-the-counter (OTC) drugs or health products within 2 weeks prior to Day -1, unless with a washout period of more than 5 half-lives for products with a longer half-life. The Principal Investigator may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.
10. Was vaccinated within 2 weeks prior to screening or plan to be vaccinated during the study.
11. Had major surgery within 6 months prior to screening or plan to undergo surgery during the study.
12. Participants who smoked more than 5 cigarettes/pipes/vaping per day on average or excessive use of any nicotine product (> 5 products on average per day) within 3 months prior to screening and not able to abstain from smoking from screening to end of study (EoS).
13. Any other serious medical condition or abnormality that, in the Investigator's judgment, precludes the participant's safe participation in and completion of the study.
14. A positive pre-study drug or alcohol screen. A positive drug or alcohol screen test result may be verified by re-testing (up to 1 false positive result permitted) and may be followed up at the discretion of the Investigator.
15. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 21 units for males or > 14 units for females. One unit is equivalent to 10 g of alcohol and the following can be used as a guide: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (30 mL) measure of spirits.
16. The participant is unwilling to abstain from alcohol consumption from 24 hours prior to dosing until discharge from the CRU, and for 24 hours prior to all other outpatient visits to the CRU.
17. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human or humanized antibodies, fusion proteins, MDI-1228_mesylate Ophthalmic Solution excipients, any material used for assessments (e.g., fluorescein, tropicamide, etc), or a history of drug or other allergy including severe allergic reaction that in the opinion of the Investigator contraindicates their participation.
18. Participation in a clinical trial within 30 days before randomization; use of any experimental therapy within 30 days or 5 half-lives prior to randomization, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to randomization, whichever is greater.
19. Pregnant or breastfeeding WOCBP.
20. Donation within the last 3 months of > 499 mL whole blood or within 2 weeks of any volume of plasma.
21. Participant unable to provide written informed consent or participant under guardianship.
22. Unwilling or unable to follow protocol requirements, including attendance at follow up visit/s.
23. Any history of severe ocular trauma in either eye at any time.
24. Any history of any refractive surgery procedure within the past 6 months of the screening visit in either eye.
25. Current or chronic history of clinically significant ocular disease within the past 3 months of screening visit in either eye.
26. Current or chronic history of ocular infection (bacterial, viral, or fungal) or corneal irritation within the past 3 months of screening visit in either eye.
27. Abnormal tearing, OR expected regular use of prescription or expected use of OTC tear substitutes within 4 weeks prior to Day -1, and for the duration of the study.
28. Previous or expected use of ocular (topical, periocular, intravitreal), local (inhaled or nasal), or systemic steroid or glucocorticoid medications within 4 weeks prior to Day -1, and for the duration of the study.
29. At the Investigator's or delegate's discretion, any participants who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results.
30. Clinically significant findings as determined by the Investigator in other ocular examinations (e.g., conjunctival hyperemia grade >1, corneal fluorescein staining score = 2, or other chronic or acute eye disorders).
31. History of clinically significant ocular disease (glaucoma, retinal detachment, iritis, uveitis, herpetic keratitis, etc.) that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk to the participant by virtue of their participation in the study.
32. Presence of an ocular pathology such as blepharitis, conjunctivitis, uveitis, or any other ocular infection or inflammation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2024
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Medinno Pharmaceutical Technology Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sepehr Shakib, PhD
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Liang Lu, PhD
Address 0 0
Country 0 0
Phone 0 0
+86 19921188051
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05969236