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

Primary Biliary Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05624294
• Other study ID #: CS0159-001A
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: April 2023
• Source: Cascade Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Drug:
• CS0159
Tablets administered orally
• Placebo
Tablets administered orally

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Cascade Pharmaceuticals, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dose PK Parameter(C-max)	Evaluate the Peak Plasma Concentration.	day 1, day 7
Primary	Dose PK Parameter(AUC)	Evaluate the Area under the plasma concentration versus time curve.	day 1, day 7
Secondary	Food effect PK Parameter(C-max)	Evaluate the Peak Plasma Concentration.	day 10
Secondary	Food effect PK Parameter(AUC)	Evaluate the Area under the plasma concentration versus time curve.	day 10
Secondary	QTc analysis	analysize the plasma Concentration relevance to QTcF	day 1, day 7