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

Cascade Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Primary Biliary Cholangitis

Treatments: Drug: CS0159; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05624294

CS0159-001A

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

2mg CS0159

Experimental group

Description:

One tablet daily for seven days.

Treatment:

Drug: CS0159

Drug: Placebo

4mg CS0159

Experimental group

Description:

Two tablet daily for seven days.

Treatment:

Drug: CS0159

Drug: Placebo

6mg CS0159

Experimental group

Description:

Three tablet daily for seven days.

Treatment:

Drug: CS0159

Drug: Placebo