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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04829123




Registration number
NCT04829123
Ethics application status
Date submitted
25/03/2021
Date registered
2/04/2021

Titles & IDs
Public title
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Scientific title
A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Secondary ID [1] 0 0
HEC88473-DM-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HEC88473 injection
Treatment: Drugs - Placebo

Experimental: Single dose of 0.5 mg HEC88473 - Healthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 1.7 mg HEC88473 - Healthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 5.1 mg HEC88473 - Healthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 10.2 mg HEC88473 - Healthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 17.0 mg HEC88473 - Healthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 25.5 mg HEC88473 - Healthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 34.0 mg HEC88473 - Healthy subjects, receiving a single dose of 34.0 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Single dose of 44.2 mg HEC88473 - Healthy subjects, receiving a single dose of 44.2 mg HEC88473 (N=6) or placebo(N=2) after meal.

Experimental: Multiple doses of 1.7 mg HEC88473 - Healthy subjects, receiving a weekly dose of 1.7 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.

Experimental: Multiple doses of 5.1 mg HEC88473 - Healthy subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.

Experimental: Multiple doses of 10.2 mg HEC88473 - Healthy subjects, receiving a weekly dose of 10.2 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.


Treatment: Drugs: HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen

Treatment: Drugs: Placebo
Placebo will be administered by subcutaneous injection in the abdomen
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Timepoint [1] 0 0
Baseline to day 15
Primary outcome [2] 0 0
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Timepoint [2] 0 0
Baseline to day 43
Primary outcome [3] 0 0
Cmax
Timepoint [3] 0 0
Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Primary outcome [4] 0 0
AUC
Timepoint [4] 0 0
Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Secondary outcome [1] 0 0
OGTT
Timepoint [1] 0 0
Predose and postdose 2, 4 hours
Secondary outcome [2] 0 0
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
Timepoint [2] 0 0
Baseline to day 43

Eligibility
Key inclusion criteria
1. Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
2. Body weight = 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee).
4. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
3. History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
4. Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
5. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
6. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study.
7. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing.
8. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).

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 administering the treatment/s
The people assessing the outcomes
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
14/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/03/2022
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Scientia Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dongguan HEC Biopharmaceutical R&D 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
Charlotte Lemech, Doctor
Address 0 0
Scientia Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT04829123