NCT04480697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2021

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

July 14, 2020

Last Update Submit

April 22, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

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

    SAD: Day 1. MAD: Day 1 and Day14

  • Cmax

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

  • Tmax

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

  • AUClast

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

  • AUCinf

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

  • +5 more secondary outcomes

Study Arms (9)

SAD 10mg

EXPERIMENTAL

A single oral dose of 10 mg

Drug: HPG1860

SAD 20mg

EXPERIMENTAL

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

Drug: HPG1860

SAD 40mg

EXPERIMENTAL

A single oral dose of 40mg

Drug: HPG1860

SAD 80 mg

EXPERIMENTAL

A single oral dose of 80 mg

Drug: HPG1860

SAD 120 mg

EXPERIMENTAL

A single oral dose of 120 mg

Drug: HPG1860

SAD 150 mg

EXPERIMENTAL

A single oral dose of 150 mg

Drug: HPG1860

MAD 10mg

EXPERIMENTAL

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

Drug: HPG1860

MAD 30mg

EXPERIMENTAL

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

Drug: HPG1860

MAD 90 mg

EXPERIMENTAL

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

Drug: HPG1860

Interventions

HPG1860DRUG

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

MAD 10mgMAD 30mgMAD 90 mgSAD 10mgSAD 120 mgSAD 150 mgSAD 20mgSAD 40mgSAD 80 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaron CPC InC

Baltimore, Maryland, 21201, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Part 1 SAD: 6 cohorts Part 2 MAD: 3 cohorts
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 21, 2020

Study Start

September 23, 2019

Primary Completion

November 25, 2020

Study Completion

August 7, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

US(1)