Trials / Completed
CompletedNCT05087069
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Healthy 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 Multiple Intravenous Doses to Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- BioVersys SAS · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Safety and tolerability and Pharmacokinetics of multiple doses of BV100 in healthy volunteers
Detailed description
The study will investigate the safety and tolerability of increasing multiple intravenous doses of BV100 by assessing the Incidence of treatment-emergent adverse events (TEAEs). In addition the goal is to characterize the multiple dose pharmacokinetic profiles of rifabutin in plasma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BV100 | Rifabutin for Infusion |
| DRUG | Placebo | Saline intravenous infusion |
Timeline
- Start date
- 2021-10-08
- Primary completion
- 2022-04-08
- Completion
- 2023-01-12
- First posted
- 2021-10-21
- Last updated
- 2023-01-17
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05087069. Inclusion in this directory is not an endorsement.