Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem inClinical Healthy Subjects

Phase 1 Completed 36 enrolled Sihuan Pharmaceutical Holdings Group Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

To observe the pharmacokinetic profiles of benapenem and its major metabolites in healthy volunteers after continuous multiple-dose benapenem, providing evidence for phase Ⅱ clinical study.

Timeline

Start: 2016-03-14
Primary completion: 2016-06-02
Completion: 2016-06-02

Publications

Zhao CY, Lv Y, Zhu Y, Wei MJ, Liu MY, Ji XW, Kang ZS, Xia YH, Tian JH, Ma Y, Liu Y. A First-in-Human Safety, Tolerability, and Pharmacokinetics Study of Benapenem in Healthy Chinese Volunteers. Antimicrob Agents Chemother. 2019 Feb 26;63(3):e02188-18. doi: 10.1128/AAC.02188-18. Print 2019 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benapenem	Small molecule	250 mg	Intravenous
Subject	Benapenem	Small molecule	500 mg	Intravenous
Subject	Benapenem	Small molecule	1000 mg	Intravenous

Indications

No indication recorded.