Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of ASC42 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC42 in Healthy Subjects

This is a first in human study of single and multiple ascending doses and food effect of ASC42.

This study consists of 8 cohorts and is divided as follows:

Part Ia: Single ascending doses study including cohorts 1 to 5. Part Ib: A cross-over design of cohort 2 to study the food effect on ASC42 PK. Part II: Multiple ascending doses study including cohorts 6 to 8.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: ASC42

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • ICON early Phase Services LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Healthy male and female subjects between 18 to 65 years of age.
• Subjects' weight ≥ 50 kg and BMI within the range of 19 - 29 kg/m2.
• Physical examination and vital signs are within normal range or slightly abnormal.

Key Exclusion Criteria:

• History or current liver disease, or liver injuries.
• A positive HBsAg, HCV Ab and/or HIV Ab.
• Platelet count <150,000/mcL
• INR> 1.2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose-ASC42; ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration	Drug: ASC42; Oral tablets
Experimental: Multiple Ascending Dose-ASC42; ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days	Drug: ASC42; Oral tablets
Placebo Comparator: Single Ascending Dose-Placebo; Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration	Drug: Placebo; Oral tablets
Placebo Comparator: Multiple Ascending Dose-Placebo; Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days	Drug: Placebo; Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 21 days	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of ASC42	Evaluate the Area under the plasma concentration versus time curve after single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Cmax of ASC42	Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
t1/2 of ASC42	Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
CL/F of ASC42	Evaluate the Apparent Systemic Clearance after single and multiple oral dose of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Vd/F of ASC42	Evaluate the Apparent Volume of Distribution after single and multiple oral dose of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
Tmax of ASC42	Evaluate the Time to reach the maximum plasma concentration after single single and multiple oral doses of ASC42 administered to healthy volunteers.	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
C4	Bile acid precuisor:C4 (7αhydroxy-4-cholesten-3-one)	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.
FGF19	Bile acid precursor:FGF19 (Fibroblast growth factor 19)	On Day 1 to Day 14 after single or multiple doses, respectively. The entire study will last up to 15 days.

Collaborators and Investigators

• Sponsor: Gannex Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): June 3, 2021

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ASC42-I-CTP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No