drugset / Trial / NCT05926466
BTZ-043 Dose Evaluation in Combination and Selection
Phase 2
Unknown
90 enrolled
Michael Hoelscher
Radboud University Medical Center · collabUniversity College, London · collabUniversity of California, San Francisco · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 2B, open label study, that will compare the safety and efficacy of three experimental regimens consisting of bedaquiline and delamanid in combination with different doses of BTZ-043, a novel antibiotic, in adult participants with newly diagnosed, drug-sensitive pulmonary tuberculosis. Participants will be assigned to receive either one of the three BTZ-043-containing regimens or a comparator regimen consisting of bedaquiline, delamanid and moxifloxacin. The objective is to find the optimal dose of BTZ-043 with the highest efficacy and safety to be used in subsequent studies.
Timeline
- Start
- 2023-09-21
- Primary completion
- 2024-08
- Completion
- 2024-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BTZ-043 | Small molecule | 500 mg | Oral |
| Subject | BTZ-043 | Small molecule | 1000 mg | Oral |
| Subject | BTZ-043 | Small molecule | 1500 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
| Background | Bedaquiline | Small molecule | 100 mg | Oral |
| Background | Delamanid | Small molecule | 300 mg | Oral |