Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-22 @ 12:49 PM
Study NCT ID:
NCT04176250
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis
Sponsor:
Gates Medical Research Institute
Organization:
Study Overview
Official Title:
A Phase 2a, Dose Escalation, Controlled, Randomized Study to Evaluate Safety, Early Bactericidal Activity (EBA) and Pharmacokinetics of TBA-7371 in Adult Patients With Rifampicin-sensitive Pulmonary Tuberculosis
Status:
COMPLETED
Status Verified Date:
2023-10
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:
The purpose of this study is to assess the safety, early bactericidal activity (EBA) and pharmacokinetics of TBA-7371 in adult participants with rifampicin-sensitive tuberculosis and select dose regimen(s) for future studies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: