drugset

drugset / Trial / NCT02219971

Phase I Study of Kukoamine B Mesilate in Healthy Volunteers

NCT02219971 ↗

Phase 1 Completed 52 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 a single intravenous injection Kukoamine B Mesilate in health volunteer

Timeline

Start: 2014-08
Primary completion: 2015-05-06
Completion: 2015-05-06

Publications

Liu H, Zhao Q, Yuan Y, Wang Z, Wang T, Tian W, Zhong W, Jiang J, Chen S, Kong K, Jin C, Hu P. First-in-Human Safety, Tolerability, and Pharmacokinetics of Single-Dose Kukoamine B Mesylate in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase I Study. Infect Dis Ther. 2024 Feb;13(2):361-371. doi: 10.1007/s40121-024-00921-6. Epub 2024 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Kukoamine B Mesilate	Unknown	0.005 mg/kg	Intravenous
Subject	Kukoamine B Mesilate	Unknown	0.02 mg/kg	Intravenous
Subject	Kukoamine B Mesilate	Unknown	0.04 mg/kg	Intravenous
Subject	Kukoamine B Mesilate	Unknown	0.08 mg/kg	Intravenous
Subject	Kukoamine B Mesilate	Unknown	0.12 mg/kg	Intravenous
Subject	Kukoamine B Mesilate	Unknown	0.24 mg/kg	Intravenous
Subject	Kukoamine B Mesilate	Unknown	0.48 mg/kg	Intravenous

Indications

No indication recorded.