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

NCT05624294 | Completed Phase 1

• 1 other identifier: CS0159-001A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (3)

• 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

• Dose PK Parameter(C-max)

  Evaluate the Peak Plasma Concentration.

  day 1, day 7

• Dose PK Parameter(AUC)

  Evaluate the Area under the plasma concentration versus time curve.

  day 1, day 7

Secondary Outcomes (3)

• Food effect PK Parameter(C-max)

  day 10

• Food effect PK Parameter(AUC)

  day 10

• QTc analysis

  day 1, day 7

Study Arms (3)

2mg CS0159

EXPERIMENTAL

One tablet daily for seven days.

Drug: CS0159; Drug: Placebo

4mg CS0159

EXPERIMENTAL

Two tablet daily for seven days.

Drug: CS0159; Drug: Placebo

6mg CS0159

EXPERIMENTAL

Three tablet daily for seven days.

Drug: CS0159; Drug: Placebo

Interventions

CS0159 DRUG

Tablets administered orally

2mg CS0159; 4mg CS0159; 6mg CS0159

Placebo DRUG

Tablets administered orally

2mg CS0159; 4mg CS0159; 6mg CS0159

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: December 19, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)