Back to resultsStudy to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
Primary Purpose
Primary Biliary Cholangitis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CS0159
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis
Eligibility Criteria
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.
Sites / Locations
- Shanghai Xuhui Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
2mg CS0159
4mg CS0159
6mg CS0159
Arm Description
One tablet daily for seven days.
Two tablet daily for seven days.
Three tablet daily for seven days.
Outcomes
Primary Outcome Measures
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.
Dose PK Parameter(C-max)
Evaluate the Peak Plasma Concentration.
Dose PK Parameter(AUC)
Evaluate the Area under the plasma concentration versus time curve.
Secondary Outcome Measures
Food effect PK Parameter(C-max)
Evaluate the Peak Plasma Concentration.
Food effect PK Parameter(AUC)
Evaluate the Area under the plasma concentration versus time curve.
QTc analysis
analysize the plasma Concentration relevance to QTcF
Full Information
NCT ID
NCT05624294
First Posted
November 14, 2022
Last Updated
April 29, 2023
Sponsor
Cascade Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT05624294
Brief Title
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cascade Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cholangitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2mg CS0159
Arm Type
Experimental
Arm Description
One tablet daily for seven days.
Arm Title
4mg CS0159
Arm Type
Experimental
Arm Description
Two tablet daily for seven days.
Arm Title
6mg CS0159
Arm Type
Experimental
Arm Description
Three tablet daily for seven days.
Intervention Type
Drug
Intervention Name(s)
CS0159
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets administered orally
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events [Safety and Tolerability]
Description
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days.
Time Frame
Upto day 15
Title
Dose PK Parameter(C-max)
Description
Evaluate the Peak Plasma Concentration.
Time Frame
day 1, day 7
Title
Dose PK Parameter(AUC)
Description
Evaluate the Area under the plasma concentration versus time curve.
Time Frame
day 1, day 7
Secondary Outcome Measure Information:
Title
Food effect PK Parameter(C-max)
Description
Evaluate the Peak Plasma Concentration.
Time Frame
day 10
Title
Food effect PK Parameter(AUC)
Description
Evaluate the Area under the plasma concentration versus time curve.
Time Frame
day 10
Title
QTc analysis
Description
analysize the plasma Concentration relevance to QTcF
Time Frame
day 1, day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Liu
Organizational Affiliation
Shanghai Xuhui Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xuhui Central Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
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