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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ASC42; Drug: Placebo

• Registration Number: NCT04965337
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study Start: 2021-07-11
• Study First Posted: 2021-07-16
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Xiangya Boai Rehabilitation Hospital; 🇨🇳 Changsha, Hunan, China