drugset

drugset / Trial / NCT03237728

Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

NCT03237728 ↗

Phase 1 Completed 44 enrolled Tianjin Chasesun Pharmaceutical Co., LTD Southwest Hospital, China · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients

Timeline

Start: 2017-07-28
Primary completion: 2019-09-25
Completion: 2019-09-25

Publications

Hu XY, Zhang W, Wang D, Sun Y, Hu Z, Zang B, Feng Y, Wang H, Zhou J, Zhao Q, Liu H, Wang T, Jiang W, Wang CY, Jin C, Dong K, Chen S, Yao X, Hu P, Du B; China Critical Care Clinical Trials Group (CCCCTG). Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial. J Crit Care. 2023 Aug;76:154294. doi: 10.1016/j.jcrc.2023.154294. Epub 2023 Apr 26.

Drugs

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

Indications