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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 2026 → Jan 2027
See other at-risk trials from TenNor Therapeutics Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 2026 to Jan 2027
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 15 of 16 entries
  2. Enrollment target: 9 to 33
    • Primary and study completion dates: Jan 5, 2026 to Aug 2026
    • Trial status: Completed to Recruiting
    • Site details revised
    v5
  3. Trial status: Recruiting to Completed
    • Enrollment target: estimated 33 to confirmed 9
    • Primary and study completion dates changed from estimate of Aug 2026 to Jan 5, 2026
    • Site details revised
    v4
  4. Enrollment target: 23 to 33v3 Show 6 more changesShow less
    • Interventions: Oral antibiotics (Drug), TNP-2092 for injection (Drug), Vancomycin Hydrochloride for Injection (IA) (Drug), Vancomycin Hydrochloride for… to Background Treatment (Drug), Oral antibiotics (Drug), TNP-2092 for injection (Drug), Vancomycin Hydrochloride for Injection (IA) (Drug)…
    • Secondary endpoints: details revised at 16 of 16 entries
    • Study description expanded, about 18 words
    • Study arms: 3 to 4
    • Eligibility criteria shortened, about 3 words
    • Study title shortened, about 5 words
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2025 to Apr 3, 2025
    • Site details revised
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06889701
Lead Sponsor TenNor Therapeutics Inc.
Collaborators: First Affiliated Hospital of Xinjiang Medical University
Conditions
(from sponsor)		 Periprosthetic Joint Infection (PJI)
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov