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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965337
• Other study ID #: ASC42-102
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: June 2022
• Source: Ascletis Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ASC42
ASC42 tablet administered orally
• Placebo
Matching placebo administered orally

Locations

Country	Name	City	State
China	Xiangya Boai Rehabilitation Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of ASC42	Evaluate the Area under the plasma concentration versus time curve.	Up to 4 days
Primary	Cmax of ASC42	Evaluate the Peak Plasma Concentration.	Up to 4 days
Secondary	t1/2 of ASC42	Evaluate the Terminal-Phase Half-Life.	Up to 4 days
Secondary	CL/F of ASC42	Evaluate the Apparent Systemic Clearance.	Up to 4 days
Secondary	Vd/F of ASC42	Evaluate the Apparent Volume of Distribution.	Up to 4 days
Secondary	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 7 days.	Up to 7 days