BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase
Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal
activity of BTZ-043 administered orally once daily over 14 days to participants with newly
diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis.
The primary objective is to assess the safety and tolerability of BTZ-043 given over 14 days
by evaluation of adverse events during treatment and follow-up period in patients with newly
diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Michael Hoelscher
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP) German Federal Ministry of Education and Research Radboud University