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Completed

NCT Number: NCT04480697

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC InC

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HPG1860

Drug

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

Primary outcomes

  1. After single ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts

    Time frame: Day1-8

    To investigate the safety and tolerability of orally administered SAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.

  2. After multiple ascending doses, number of subjects with treatment-emergent adverse events(TEAEs) in the HPG1860 dose-level cohorts

    Time frame: Day1-21

    To investigate the safety and tolerability of orally administered MAD of HPG1860 by assessment of AEs, vital signs and clinical laboratory findings.

Secondary outcomes

  1. Effect of HPG1860 on Blood Concentration of FGF19 and 7-alpha-hydroxy-4-cholesten-3-one (C4)

    Time frame: SAD: Day 1. MAD: Day 1 and Day14

    To assess blood FGF19 and C4 changes vs placebo after orally administered SAD and MAD of HPG1860

  2. Cmax

    Time frame: SAD: up to 48 hours ; MAD: up to 14 days.

    Maximum observed serum concentration

  3. Tmax

    Time frame: SAD: up to 48 hours ; MAD: up to 14 days.

    Time to reach Cmax

  4. AUClast

    Time frame: SAD: up to 48 hours ; MAD: up to 14 days.

    Area under the curve from the time of dosing to the time of the last measurable concentration

  5. AUCinf

    Time frame: SAD: up to 48 hours ; MAD: up to 14 days.

    Area under the curve from the time of dosing extrapolated to infinity

  6. CL

    Time frame: SAD: up to 48 hours; MAD: up to 14 days

    Apparent total body clearance of the drug from plasma

  7. Vd

    Time frame: SAD: up to 48 hours; MAD: up to 14 days

    Apparent volume of distribution

  8. Effect of Food on Cmax of HPG1860

    Time frame: up to 48 hours

    To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating Cmax

  9. Effect of Food on AUCinf of HPG1860

    Time frame: up to 48 hours

    To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUCinf

  10. Effect of Food on AUC0-24h of HPG1860

    Time frame: 24 hours

    To assess the effect of food on a single dose of 20 mg HPG1860 by evaluating AUC0-24h

Sponsors and collaborators

Lead sponsor

Hepagene (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 21, 2020
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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