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

Hepagene

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HPG1860

Study type: Interventional

Funder types: Industry

Identifiers

NCT04480697

HPG1860-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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56 participants in 9 patient groups

SAD 10mg

Experimental group

Description:

A single oral dose of 10 mg

Treatment:

Drug: HPG1860

SAD 20mg

Experimental group

Description:

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

Treatment:

Drug: HPG1860

SAD 40mg

Experimental group

Description:

A single oral dose of 40mg

Treatment:

Drug: HPG1860

SAD 80 mg

Experimental group

Description:

A single oral dose of 80 mg

Treatment:

Drug: HPG1860

SAD 120 mg

Experimental group

Description:

A single oral dose of 120 mg

Treatment:

Drug: HPG1860

SAD 150 mg

Experimental group

Description:

A single oral dose of 150 mg

Treatment:

Drug: HPG1860

MAD 10mg

Experimental group

Description:

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

Treatment:

Drug: HPG1860

MAD 30mg

Experimental group

Description:

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

Treatment:

Drug: HPG1860

MAD 90 mg

Experimental group

Description:

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

Treatment:

Drug: HPG1860