Status:
COMPLETED
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Lead Sponsor:
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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
Detailed Description
This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and mul...
Eligibility Criteria
Inclusion
- Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
- Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
- 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).
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion
- 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).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
- 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.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
- 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.
- 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.
- 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).
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04829123
Start Date
May 14 2021
End Date
March 2 2022
Last Update
February 15 2023
Active Locations (1)
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1
Scientia Clinical Research
Sydney, Australia