Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 8:31 AM
Study NCT ID:
NCT05087069
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2021-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Healthy Male Subjects
Sponsor:
BioVersys SAS
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: