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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04829123
Registration number
NCT04829123
Ethics application status
Date submitted
25/03/2021
Date registered
2/04/2021
Date last updated
15/02/2023
Titles & IDs
Public title
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
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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
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Secondary ID [1]
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HEC88473-DM-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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Metabolic disorders
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
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Assessment method [1]
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Timepoint [1]
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Baseline to day 15
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Primary outcome [2]
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Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
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Assessment method [2]
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Timepoint [2]
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Baseline to day 43
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Primary outcome [3]
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Cmax
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Assessment method [3]
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Maximum observed plasma concentration of HEC88473
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Timepoint [3]
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Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
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Primary outcome [4]
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AUC
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Assessment method [4]
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Area under the plasma concentration-time curve (AUC)
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Timepoint [4]
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Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
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Secondary outcome [1]
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OGTT
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Assessment method [1]
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Oral glucose tolerance test
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Timepoint [1]
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Predose and postdose 2, 4 hours
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Secondary outcome [2]
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Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
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Assessment method [2]
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Timepoint [2]
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Baseline to day 43
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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.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/03/2022
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Scientia Clinical Research - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety,
tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04829123
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Charlotte Lemech, Doctor
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Address
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Scientia Clinical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04829123
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