Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159

Summary

The whole study includes 2 parts. Both the SAD study and MAD study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of CS0159. The SAD part also involves a pilot food effect (FE) study, designed to assess the food effect on single-dose PK profile in healthy subjects.

Timeline

Start

2021-10-26

Primary completion

2022-09-16

Completion

2022-10-12

Publications

• Zang Y, Shi J, Zhao G, Tang B, Liu M, Yao B, Wang G, Pan H, Yang S, Deng R, Zhao Y, Zhang Z, Guo HR, Sun DD, Wang H, Gao L, Yu J, Diao X, Li Y, Li J, Xu HE. A first-in-class pulsatile FXR agonist for bile-acid-related liver diseases. Nature. 2026 Jun 10. doi: 10.1038/s41586-026-10633-1. Online ahead of print.

Drugs

Indications