drugset / Trial / NCT04608955

Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081

NCT04608955

Phase 2 Completed 99 enrolled Shanghai Jiatan Pharmatech Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive\&susceptible and drug-resistant tuberculosis. Also the efficacy of WX-081 will be explored in participants with drug-resistant tuberculosis.

Timeline

Start
2020-10-16
Primary completion
2022-04-13
Completion
2022-04-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bedaquiline Small molecule 200 mg Oral
Subject Sudapyridine Small molecule 150 mg Oral
Subject Sudapyridine Small molecule 300 mg Oral
Subject Sudapyridine Small molecule 450 mg Oral