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

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled, Single and Multiple Ascending Doses (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HPG1860

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480697
• Other study ID #: HPG1860-101
• Status: Completed
• Phase: Phase 1
• Start date: September 23, 2019
• Est. completion date: August 7, 2021

Study information

• Verified date: April 2022
• Source: Hepagene (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 7, 2021
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HPG1860
6 subjects randomized to active compound and 2 subjects randomized to placebo

Locations

Country	Name	City	State
United States	Pharmaron CPC InC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hepagene (Shanghai) Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	After single ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts	To investigate the safety and tolerability of orally administered SAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.	Day1-8
Primary	After multiple ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts	To investigate the safety and tolerability of orally administered MAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.	Day1-21
Secondary	Effect of HPG1860 on Blood Concentration of FGF19 and 7-alpha-hydroxy-4-cholesten-3-one (C4)	To assess blood FGF19 and C4 changes vs placebo after orally administered SAD and MAD of HPG1860	SAD: Day 1. MAD: Day 1 and Day14
Secondary	Cmax	Maximum observed serum concentration	SAD: up to 48 hours ; MAD: up to 14 days.
Secondary	Tmax	Time to reach Cmax	SAD: up to 48 hours ; MAD: up to 14 days.
Secondary	AUClast	Area under the curve from the time of dosing to the time of the last measurable concentration	SAD: up to 48 hours ; MAD: up to 14 days.
Secondary	AUCinf	Area under the curve from the time of dosing extrapolated to infinity	SAD: up to 48 hours ; MAD: up to 14 days.
Secondary	CL	Apparent total body clearance of the drug from plasma	SAD: up to 48 hours; MAD: up to 14 days
Secondary	Vd	Apparent volume of distribution	SAD: up to 48 hours; MAD: up to 14 days
Secondary	Effect of Food on Cmax of HPG1860	To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating Cmax	up to 48 hours
Secondary	Effect of Food on AUCinf of HPG1860	To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUCinf	up to 48 hours
Secondary	Effect of Food on AUC0-24h of HPG1860	To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUC0-24h	24 hours