drugset
drugset / Trial / NCT06889701

A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants

NCT06889701 ↗

Phase 1/2 Recruiting 33 enrolled TenNor Therapeutics Limited First Affiliated Hospital of Xinjiang Medical University · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and oral antibiotics therapy in participants with early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacements and revision surgeries).

Timeline

Start
2025-04-03
Primary completion
2026-08
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject RIFAQUIZINONE Small molecule 50 mg Other
Background Vancomycin Other / unclassified 0.5 g Other
Background Levofloxacin Small molecule 0.5 g Oral
Background Minocycline Small molecule 100 mg Oral
Background Rifampin Small molecule 0.45 g Oral
Background Vancomycin Other / unclassified 1 g Intravenous

Indications

periprosthetic joint infection