NCT05624294

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Cascade Pharmaceuticals, Inc · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	CS0159	Tablets administered orally
DRUG	Placebo	Tablets administered orally

Timeline

• Start date: 2022-12-19
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2022-11-22
• Last updated: 2023-05-03

Locations

1 site across 1 country: China