Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Male Subjects

Phase 1 Completed 54 enrolled BioVersys SAS

RandomizedSequentialQuadruple-blindTreatment

Summary

This is a Phase 1, single-centre, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy male subjects.

Timeline

Start: 2020-11-09
Primary completion: 2021-12-12
Completion: 2022-01-20

Publications

Kemmer C, Hirsch M, Reh C, Davila M, Jung F, Husband L, Dale GE. Single-ascending and multiple-ascending dose study of the pharmacokinetics, safety, and tolerability of BV100 (rifabutin for infusion) in healthy volunteers. Antimicrob Agents Chemother. 2026 Apr;70(4):e0158225. doi: 10.1128/aac.01582-25. Epub 2026 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rifabutin	Small molecule	—	Intravenous

Indications

No indication recorded.