drugset / Trial / NCT07170800
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.
Timeline
- Start
- 2025-09-19
- Primary completion
- 2026-02-28
- Completion
- 2026-09-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Delamanid | Small molecule | 100 mg | — |
| Subject | JDB0131 | Small molecule | 100 mg | — |
| Subject | JDB0131 | Small molecule | 200 mg | — |
| Background | Bedaquiline | Small molecule | 200 mg | — |
| Background | Clofazimine | Small molecule | 100 mg | — |
| Background | Levofloxacin | Small molecule | 750 mg | — |
| Background | Levofloxacin | Small molecule | 1000 mg | — |
| Background | Linezolid | Other / unclassified | 600 mg | — |
| Background | Moxifloxacin | Small molecule | 400 mg | — |