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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-11

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Relative Bioavailability of ASC41 in Healthy Subjects

NCT04527250

Healthy

COMPLETED PHASE1

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

NCT04679129

Healthy

COMPLETED PHASE1

Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects

NCT04352361

Healthy

COMPLETED PHASE1

Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Administration of HS-10356 in Healthy Volunteers

NCT04652297

Healthy

UNKNOWN PHASE1

Ascending Single-Dose and Multiple-Dose Study to Evaluate RJ4287 in Healthy Subjects

NCT05921006

Drug Safety

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASC42 Dose A

ASC42 tablet Dose A, once daily

Group Type EXPERIMENTAL

ASC42

Intervention Type DRUG

ASC42 tablet administered orally

Placebo Dose A

Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo administered orally

ASC42 Dose B

ASC42 tablet Dose B, once daily

Group Type EXPERIMENTAL

ASC42

Intervention Type DRUG

ASC42 tablet administered orally

Placebo Dose B

Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASC42

ASC42 tablet administered orally

Intervention Type DRUG

Placebo

Matching placebo administered orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes