The Single, Multiple Dose and Food Effect Study of SHR2285 Tablets on Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Summary

The study is a randomized, doubled-blinded, placebo-controlled, Phase I trials. The study is divided into two parts. The first part is a single-dose escalated study (SAD,part 1A ) and food effect study (SAD, part 1B ) in healthy subjects. The second part is a multi-dose escalated study (MAD) in healthy subjects.

Timeline

Start

2020-08-28

Primary completion

2021-05-31

Completion

2021-05-31

Publications

• Xu J, Zhao N, Huang J, Li J, Zhao X, Xiang Q, Yang S, Dong Y, Wang H, Li Y, Yang G, Cui Y. The Safety, Pharmacokinetics, and Pharmacodynamics of SHR2285, an Oral Small Molecule Factor XIa Inhibitor, in Healthy Chinese Volunteers. Clin Drug Investig. 2023 Jun;43(6):435-445. doi: 10.1007/s40261-023-01281-8. Epub 2023 Jun 16.

Drugs

Indications