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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04965337

Enrollment

Registered

2021-07-16

Start date

2021-07-11

Completion date

2021-08-01

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Subjects, ASC42, FXR agonist

Brief summary

This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.

Interventions

DRUGASC42

ASC42 tablet administered orally

DRUGPlacebo

Matching placebo administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Healthy male and female volunteers aged 18-55 years. * 19kg/m2 ≤ BMI \<24kg/m2. Key

Exclusion criteria

* A positive HBsAg, HCV Ab and/or HIV Ab. * Pancreatic injury or pancreatitis. * History of organ transplantation, including bone marrow transplantation.

Design outcomes

Primary

Measure	Time frame	Description
AUC of ASC42	Up to 4 days	Evaluate the Area under the plasma concentration versus time curve.
Cmax of ASC42	Up to 4 days	Evaluate the Peak Plasma Concentration.

Secondary

Measure	Time frame	Description
t1/2 of ASC42	Up to 4 days	Evaluate the Terminal-Phase Half-Life.
CL/F of ASC42	Up to 4 days	Evaluate the Apparent Systemic Clearance.
Vd/F of ASC42	Up to 4 days	Evaluate the Apparent Volume of Distribution.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Up to 7 days	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 7 days.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026