BTZ-043 Dose Evaluation in Combination and Selection
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Michael Hoelscher
Collaborators:
Radboud University Medical Center University College, London University of California, San Francisco