drugset / Trial / NCT03334734
Phase 2a Study of PBTZ169
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Isoniazid | Small molecule | 600 mg | — |
| Subject | MACOZINONE | Small molecule | 160 mg | — |
| Subject | MACOZINONE | Small molecule | 320 mg | — |
| Subject | MACOZINONE | Small molecule | 640 mg | — |