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

Phase 1

Completed

• Conditions: Primary Biliary Cholangitis
• Interventions: Drug: CS0159; Drug: Placebo

• Registration Number: NCT05624294
• Lead Sponsor: Cascade Pharmaceuticals, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-22
• Study Start: 2022-12-19
• Primary Completion: 2023-03-28
• Study Completion: 2023-03-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-29
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Healthy adult subjects of 18 years to 55 years.
2. Weight: Male≥50kg, female≥45kg BMI: 18~32kg/m².
3. 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.
4. Subject signs IFC and dates and subject must understand and follow test procedures and restrictions.

Exclusion Criteria

1. Subjects with special dietary requirements and cannot follow a uniform diet.
2. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
3. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2mg CS0159	CS0159	One tablet daily for seven days.
2mg CS0159	Placebo	One tablet daily for seven days.
4mg CS0159	CS0159	Two tablet daily for seven days.
4mg CS0159	Placebo	Two tablet daily for seven days.
6mg CS0159	CS0159	Three tablet daily for seven days.
6mg CS0159	Placebo	Three tablet daily for seven days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Xuhui Central Hospital; 🇨🇳 Shanghai, China