Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects

Study Overview
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Brief Summary
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This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.

Official Title
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A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects

Conditions
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Primary Biliary Cholangitis

Intervention / Treatment
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* Drug: CS0159
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult subjects of 18 years to 55 years. Weight: Male≥50kg, female≥45kg BMI: 18 32kg/m². In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation. Subject signs IFC and dates and subject must understand and follow test procedures and restrictions. Exclusion Criteria: Subjects with special dietary requirements and cannot follow a uniform diet. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2mg CS0159<br>One tablet daily for seven days. | Drug: CS0159<br>* Tablets administered orally<br>Drug: Placebo<br>* Tablets administered orally<br>|
| Experimental: 4mg CS0159<br>Two tablet daily for seven days. | Drug: CS0159<br>* Tablets administered orally<br>Drug: Placebo<br>* Tablets administered orally<br>|
| Experimental: 6mg CS0159<br>Three tablet daily for seven days. | Drug: CS0159<br>* Tablets administered orally<br>Drug: Placebo<br>* Tablets administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days. | Upto day 15 | 
| Dose PK Parameter(C-max) | Evaluate the Peak Plasma Concentration. | day 1, day 7 | 
| Dose PK Parameter(AUC) | Evaluate the Area under the plasma concentration versus time curve. | day 1, day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food effect PK Parameter(C-max) | Evaluate the Peak Plasma Concentration. | day 10 | 
| Food effect PK Parameter(AUC) | Evaluate the Area under the plasma concentration versus time curve. | day 10 | 
| QTc analysis | analysize the plasma Concentration relevance to QTcF | day 1, day 7 |