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

NCT ID: NCT04480697

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2021-08-07

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 HPG1860 orally administered in healthy subjects.

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. 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SAD 10mg

A single oral dose of 10 mg

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

SAD 20mg

A single oral dose of 20 mg. Food effect will also be assessed at the same dose level.

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

SAD 40mg

A single oral dose of 40mg

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

SAD 80 mg

A single oral dose of 80 mg

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

SAD 120 mg

A single oral dose of 120 mg

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

SAD 150 mg

A single oral dose of 150 mg

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

MAD 10mg

Dose regimen is once daily 10 mg for 14 consecutive days.

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

MAD 30mg

Dose regimen is once daily 30 mg for 14 consecutive days.

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

MAD 90 mg

Dose regimen is once daily 90mg for 14 consecutive days.

Group Type: EXPERIMENTAL

HPG1860

Intervention Type: DRUG

6 subjects randomized to active compound and 2 subjects randomized to placebo

Interventions

HPG1860

6 subjects randomized to active compound and 2 subjects randomized to placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy subjects aged 18-55 years old (inclusive), male or female

2. Females must be of non-childbearing potential

3. 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

1. 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

2. Taken an investigational drug within 3 months or 5 half-live, whichever is longer from the Screening date

3. Any liver function panel analyte (LFT) value > upper limits of normal reference range

4. 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

5. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hepagene (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pharmaron CPC InC

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HPG1860-101

Identifier Type: -

Identifier Source: org_study_id