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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05624294

Enrollment

Registered

2022-11-22

Start date

2022-12-19

Completion date

2023-03-28

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

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.

Interventions

DRUGCS0159

Tablets administered orally

DRUGPlacebo

Tablets administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026