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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-06-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Ascending Dose-ASC42

ASC42 tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration

Group Type EXPERIMENTAL

ASC42

Intervention Type DRUG

Oral tablets

Multiple Ascending Dose-ASC42

ASC42 tablet, Dose 1，Dose 2，Dose 3，q.d.×14 days

Group Type EXPERIMENTAL

ASC42

Intervention Type DRUG

Oral tablets

Single Ascending Dose-Placebo

Placebo tablet，Dose 1，Dose 2，Dose 3，Dose 4，and Dose 5, single dose administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets

Multiple Ascending Dose-Placebo

Placebo tablet，Dose 1，Dose 2，Dose 3，q.d.×14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets

Interventions

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ASC42

Oral tablets

Intervention Type DRUG

Placebo

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.