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Clinical Trial Summary

This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose Bedaquiline, Delamanid and Moxifloxacin alone

Clinical Trial Description

This will be an open label Phase IIb dose-finding, randomized, controlled study with a duration of 16 weeks of experimental therapy of Delpazolid(DZD) - Bedaquiline/Delamanid/ Moxifloxacin (BDM) in adult patients with newly diagnosed, smear positive, uncomplicated, drug sensitive pulmonary tuberculosis (TB) to evaluate the safety, efficacy, tolerability, pharmacokinetics and exposure/response-relationship of different doses of delpazolid in combination with bedaquiline, delamanid and moxifloxacin. Participants will be randomized to one of five arms containing BDM standard dose with different doses of DZD. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04550832
Study type Interventional
Source LigaChem Biosciences, Inc.
Status Completed
Phase Phase 2
Start date October 22, 2021
Completion date September 11, 2023

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