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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ASC42
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC42 Dose A<br>ASC42 tablet Dose A, once daily | Drug: ASC42<br>* ASC42 tablet administered orally<br>|
| Placebo Comparator: Placebo Dose A<br>Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily | Drug: Placebo<br>* Matching placebo administered orally<br>|
| Experimental: ASC42 Dose B<br>ASC42 tablet Dose B, once daily | Drug: ASC42<br>* ASC42 tablet administered orally<br>|
| Placebo Comparator: Placebo Dose B<br>Placebo Comparator: Single dose of matched placebo to ASC42 tablet Dose A, once daily | Drug: Placebo<br>* Matching placebo administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ASC42 | Evaluate the Area under the plasma concentration versus time curve. | Up to 4 days | 
| Cmax of ASC42 | Evaluate the Peak Plasma Concentration. | Up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t1/2 of ASC42 | Evaluate the Terminal-Phase Half-Life. | Up to 4 days | 
| CL/F of ASC42 | Evaluate the Apparent Systemic Clearance. | Up to 4 days | 
| Vd/F of ASC42 | Evaluate the Apparent Volume of Distribution. | Up to 4 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Subjects, ASC42, FXR agonist