NCT04636983

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

A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 Administered as Single Intravenous Doses to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: BioVersys SAS · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purpose of this First in human study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy subjects. Participants will either receive one single intravenous infusion of BV100 or placebo (physiological saline 0.9% w/v).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	BV100	Rifabutin IV
DRUG	Placebo	Saline

Timeline

• Start date: 2020-11-09
• Primary completion: 2021-12-12
• Completion: 2022-01-20
• First posted: 2020-11-19
• Last updated: 2022-02-08

Locations

1 site across 1 country: Germany