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drugset / Trial / NCT02690961

Study of Multiple-dose Kukoamine B Mesilate in Healthy Volunteers

NCT02690961 ↗

Phase 1 Completed 24 enrolled Tianjin Chasesun Pharmaceutical Co., LTD Southwest Hospital, China · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess safety, tolerance and pharmacokinetics of Multiple-dose Kukoamine B Mesilate in healthy volunteers

Timeline

Start: 2016-03
Primary completion: 2016-06-14
Completion: 2016-06-14

Publications

Zhao Q, Liu H, Wang Z, Wang T, Cui C, Wang H, Li L, Zhong W, Jiang J, Dong K, Chen S, Jin C, Hu P. Safety, Tolerability, and Pharmacokinetics of Kukoamine B in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Phase I Study. Adv Ther. 2023 Jul;40(7):3186-3198. doi: 10.1007/s12325-023-02521-1. Epub 2023 May 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Kukoamine B	Small molecule	0.06 mg/kg	Intravenous
Subject	Kukoamine B	Small molecule	0.12 mg/kg	Intravenous
Subject	Kukoamine B	Small molecule	0.24 mg/kg	Intravenous

Indications

No indication recorded.