Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Michael Hoelscher
Collaborators:
CMed Technologies Inc. European and Developing Countries Clinical Trials Partnership (EDCTP) German Federal Ministry of Education and Research Parexel PathCare Quintiles, Inc. Sequella, Inc.