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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04480697

Run by

Hepagene (Shanghai) Co., Ltd.

People needed

56

Starts

2019-09-23

Expected to finish

2021-08-07

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pharmaron CPC InC — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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