drugset / Trial / NCT03334734

Phase 2a Study of PBTZ169

NCT03334734 ↗

Phase 2 Terminated 16 enrolled Nearmedic Plus LLC OCT LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Multicenter, open, randomized study with active control (isoniazid) to evaluate the early antibacterial activity, safety and pharmacokinetics of the drug PBTZ169 (capsules 80 mg) when used in patients with first-diagnosed tuberculosis of the respiratory system with bacterial excretion and saved bacterial susceptibility to isoniazid and rifampicin

Timeline

Start
2016-12-16
Primary completion
2017-09-10
Completion
2018-02-22

Outcome

Outcome not reported

Stopped (Enrollment): “Very slow enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Isoniazid Small molecule 600 mg —
Subject MACOZINONE Small molecule 160 mg —
Subject MACOZINONE Small molecule 320 mg —
Subject MACOZINONE Small molecule 640 mg —

Indications