An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers

Phase 1 Unknown 40 enrolled Lee's Pharmaceutical Limited

Non-randomizedSequentialOpen-labelBasic science

Summary

The subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And returned to the research center for follow-up on the day 28 and 35.

Timeline

Start: 2020-04-19
Primary completion: 2020-12-05
Completion: 2020-12-30

Publications

Zhou Q, Wang Z, Wang H, Chen Z, Li X, Dai X, Zhang Y, Yu X, Zhou R, Hu W. Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. Am J Cardiovasc Drugs. 2023 Jan;23(1):101-112. doi: 10.1007/s40256-022-00562-5. Epub 2023 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tecarfarin	Small molecule	10 mg	Oral
Subject	Tecarfarin	Small molecule	20 mg	Oral
Subject	Tecarfarin	Small molecule	30 mg	Oral
Subject	Tecarfarin	Small molecule	40 mg	Oral

Indications

No indication recorded.