Phase 2 Study of TBD09 Combined With Bedaquiline and Pretomanid or Linezolid for Treating Drug-Sensitive Pulmonary Tuberculosis in Adults

What this Trial Is About

Researchers are evaluating the safety and bactericidal activity of TBD09 combined with other drugs in adults with drug-sensitive pulmonary tuberculosis. This Phase 2 randomized trial aims to determine if these combinations are safe and effective for treating this form of tuberculosis. The study is sponsored by the Gates Medical Research Institute and involves multiple treatment groups with varying doses of TBD09. Participants are assigned to one of five groups receiving different combinations of TBD09, bedaquiline, pretomanid, and linezolid. The TBD09 doses vary from 100 mg three times weekly to 500 mg daily, combined with bedaquiline and pretomanid, or linezolid with bedaquiline and pretomanid. Treatment lasts for 28 days in each group. During the study, participants will be monitored through Day 35 for safety, including serious adverse events, treatment-emergent adverse events, and adverse events leading to treatment discontinuation. Researchers will also assess bactericidal activity up to Day 28 and study pharmacokinetics of TBD09. Additional safety evaluations include blood tests, visual and color vision assessments, and peripheral neuropathy screening. The total participation period covers screening, treatment, and follow-up assessments.

Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis