Study of Safety Tolerability and PK PD of HPG1860 in Healthy Subjects

  • STATUS
    Recruiting
  • participants needed
    72
  • sponsor
    Hepagene (Shanghai) Co., Ltd.
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Updated on 16 February 2024
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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 HPG1860 orally administered in healthy subjects.

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. Blood samples will be collected for safety, PK and PD assessments. After the completion of Cohort 2 (20 mg) in SAD study, following a 7-day washout period, the same 8 subjects will receive another single oral dose of 20 mg HPG1860 after a standard high fat/high calorie breakfast (the fed condition). PK blood samplings will be collected and Cmax and AUC will be used for assessing the food effect. In MAD study, there are 3 cohorts (8 subjects/cohort) with dose levels of 10mg, 30mg and 90 mg, respectively and dosing regimen is once daily for 14 consecutive days. Blood samples will be collected for safety, PK and PD assessments.

Details
Condition Healthy
Age 18years - 55years
Treatment HPG1860
Clinical Study IdentifierNCT04480697
SponsorHepagene (Shanghai) Co., Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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