drugset / Trial / NCT01218217
Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB
Phase 2
Completed
90 enrolled
Michael Hoelscher
CMed Technologies Inc. · collabEuropean and Developing Countries Clinical Trials Partnership (EDCTP) · collabGerman Federal Ministry of Education and Research · collabParexel · collabPathCare · collabQuintiles, Inc. · collabSequella, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
SQ109 was developed with the aim of shortening TB treatment and providing new drugs for resistant TB. The drug has demonstrated efficacy in toxicology studies and an acceptable safety profile in first-in-man studies. The objective of this study is to evaluate the extended early bactericidal activity (EBA), safety, tolerability, and pharmacokinetics of several doses of SQ109 with or without Rifampicin (RIF) for 14 days in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-09
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifampin | Small molecule | 150 mg | — |
| Subject | SQ109 | Small molecule | 75 mg | — |
| Subject | SQ109 | Small molecule | 150 mg | — |
| Subject | SQ109 | Small molecule | 300 mg | — |