Status:
COMPLETED
Study of Safety, Tolerability and PK, PD of HPG1860 in Healthy Subjects
Lead Sponsor:
Hepagene (Shanghai) Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HPG1...
Detailed Description
In SAD and MAD studies, all subjects are randomized in a 3:1 ratio. In SAD study , there are 6 cohorts (8 subjects/cohort) with dose levels of 10mg, 20 mg, 40 mg, 80 mg, 120 mg and 150 mg respectively...
Eligibility Criteria
Inclusion
- Healthy subjects aged 18-55 years old (inclusive), male or female
- Females must be of non-childbearing potential
- Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) and weigh at least 50 kg at time of Screening
Exclusion
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator
- Taken an investigational drug within 3 months or 5 half-live, whichever is longer from the Screening date
- Any liver function panel analyte (LFT) value \> upper limits of normal reference range
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B core (IgG and IgM) and surface antigen (HBsAg), Hepatitis A antibody (IgM), hepatitis C antibody (IgG), or hepatitis E (IgG and IgM) at Screening
- Any condition or finding that in the opinion of the Principal Investigator or designee would put the subject or study conduct at risk if the subject were to participate in the study
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04480697
Start Date
September 23 2019
End Date
August 7 2021
Last Update
April 25 2022
Active Locations (1)
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1
Pharmaron CPC InC
Baltimore, Maryland, United States, 21201