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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06372652




Registration number
NCT06372652
Ethics application status
Date submitted
15/04/2024
Date registered
18/04/2024

Titles & IDs
Public title
A Phase 1 Study of TE-8214 Solution in Healthy Volunteers
Scientific title
A Randomized, Double-blinded, Placebo-controlled Phase 1 Study of a Single Dose of a Subcutaneous Ultra-Long-Acting Somatostatin Analog (TE-8214 Solution) to Investigate the Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers
Secondary ID [1] 0 0
TE-8214-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TE-8214 - SAD
Treatment: Drugs - Placebo

Experimental: SAD Cohort - Each participant will receive TE-8214 administered by subcutaneous injection across 5 Cohorts (Cohort 5 optional)

Experimental: Placebo - Each participant will receive matching volume doses of Placebo administered by subcutaneous injection


Treatment: Drugs: TE-8214 - SAD
Cohort 1 - Single subcutaneous dose of 0.6 mg Cohort 2- Single subcutaneous dose of 1.2 mg Cohort 3 - Single subcutaneous dose of 2.0 mg Cohort 4 - Single subcutaneous dose of 3.0 mg or 4.0 mg Cohort 5 (Optional) - Single subcutaneous dose of 6.0 mg

Treatment: Drugs: Placebo
Single subcutaneous dose of matching placebo across the cohorts
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
From administration of IP on Day 1 until the EOS/ET visit (Day 84) post dose
Primary outcome [2] 0 0
Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events
Timepoint [2] 0 0
From screening until the EOS/ET visit (Day 84) post dose
Primary outcome [3] 0 0
Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs)
Timepoint [3] 0 0
On Day 1, 0 hour, 6 hours, 12 hours, 24 hours, 48 hours,72 hours, 96 hours, 168 hours post dose
Primary outcome [4] 0 0
Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings
Timepoint [4] 0 0
From Screening until EOS/ET (Day 84) post dose
Primary outcome [5] 0 0
Safety and tolerability of TE-8214 by the changes in physical examination findings
Timepoint [5] 0 0
At Screening, Day -1, Day 2, Day 8, Day 28, Day 56, Day 84 post dose
Primary outcome [6] 0 0
Safety and tolerability of TE-8214 by the changes in ECG findings
Timepoint [6] 0 0
At Screening, Day -1, Day 1, Day 2, Day 4, Day 8, Day 14, Day 28, Day 56, Day 84 post dose
Secondary outcome [1] 0 0
PK Parameters: Maximum observed concentration (Cmax)
Timepoint [1] 0 0
On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose
Secondary outcome [2] 0 0
PK Parameters: Time to maximum observed concentration (Tmax)
Timepoint [2] 0 0
On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose
Secondary outcome [3] 0 0
PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last)
Timepoint [3] 0 0
On Day 1, Day 2, Day 3, Day 4, Day 5, Day 8, Day 10, Day 14, Day 21, Day 28, Day 56, Day 84 post dose

Eligibility
Key inclusion criteria
1. Adult, between 18 and 64 years old (inclusive, at the time of informed consent).
2. In good general health, as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening and/or before the administration of IP at the discretion of the PI or designee.
3. Sign informed consent forms which include an explanation of the nature of the study, and the expected compliance with the requirements and restrictions of the study.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any abnormal laboratory values at Screening that are considered clinically significant by the PI or designee, or evidence of clinically significant abnormal findings at the physical examination at Screening, or significant illness within 2 weeks prior to dosing.
2. Have known allergies to octreotide, somatostatin analogs, or related compounds.
3. Have abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant, including, but not limited to: PR interval > 220 ms, QTcF > 450 ms (males) or > 470 ms (females), and/or arrythmias.
4. History of clinically significant allergy (including anaphylaxis), history or clinical evidence of pancreatic injury or pancreatitis.
5. History of gallstones, prior cholecystectomy is not exclusionary.
6. History of B12 deficiency.
7. History of hypothyroidism, or TSH > 4 mIU/L at Screening.
8. Any individual with a known history of diabetes mellitus, or HbA1c = 6.5% at Screening. Individuals with previous gestational diabetes are eligible to participate, provided they do not currently have diabetes.
9. Women of childbearing potential (WOCBP) must be non-pregnant and must use an acceptable, highly effective double contraception from Screening until study completion.
10. Males must use an acceptable, highly effective double contraception from Screening until study completion and must not donate sperm until at least 90 days after the last dose of study drug.
11. Anything that the PI considers that would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
12. Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
2/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/12/2024
Actual
Sample size
Target
32
Accrual to date
Final
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
Immunwork, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ya-Shan Chuang
Address 0 0
Country 0 0
Phone 0 0
+886226512268
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/NCT06372652