Actively Recruiting
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
Led by TenNor Therapeutics Inc. · Updated on 2026-03-05
33
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
T
TenNor Therapeutics Inc.
Lead Sponsor
F
First Affiliated Hospital of Xinjiang Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of symptoms) PJI requiring or not requiring DAIR therapy after TKA, or PJI not clinically cured needing long-term antibiotic suppression
- Suspected or confirmed Gram-positive bacterial infection causing PJI, including resistant Staphylococcus aureus and Staphylococcus epidermidis
- Willing to be hospitalized for 2 weeks for intra-articular injection
- Age 18 years or older of any gender
- Implanted prosthetic joint is well fixed
- No sinus tract communicating with the prosthesis
- Body mass index (BMI) of 18 to 34 kg/m²
- Agree to use effective contraception from consent until 8 weeks after last study dose; males must avoid sperm donation during this period
You will not qualify if you...
- History of allergy or intolerance to vancomycin or TNP-2092
- Confirmed PJI caused by Gram-negative, fungal, Enterococcus, Mycobacterium, or mixed infections
- Systemic infection with sepsis
- Life expectancy less than 1 year
- Pregnancy, lactation, or positive pregnancy test at screening
- Medical or surgical conditions affecting study participation or treatment administration, including active cancer, metabolic disease, substance abuse, or major lab abnormalities
- Serious liver, blood, or immune disorders such as recent hepatitis, elevated liver enzymes, end-stage liver disease symptoms, neutropenia, recent chemotherapy or immunosuppressants, or high-dose corticosteroids
- Positive AIDS antibody test
- Severe kidney disease or creatinine clearance under 30 mL/min
- Use of another investigational drug within 30 days or 5 half-lives before first study dose
- Inability to comply with study procedures or complete the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Actively Recruiting
Research Team
L
Li Cao
CONTACT
J
Jing Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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