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

Ascletis

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASC42; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04965337

ASC42-102

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 4 patient groups, including a placebo group

ASC42 Dose A

Experimental group

Description:

ASC42 tablet Dose A, once daily

Treatment:

Drug: ASC42

Placebo Dose A

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

ASC42 Dose B

Experimental group

Description:

ASC42 tablet Dose B, once daily

Treatment:

Drug: ASC42

Placebo Dose B

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo