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

Exclusion Criteria

• •History of hypersensitivity or intolerance to any of the following agents: vancomycin or TNP-2092.
• •Definite PJI of Gram-negative infection, fungal infection, or Enterococcus infection, or Mycobacterium infection, or Gram-positive mixed Gram-negative and/or fungal infection.
• •Definite systemic infection (sepsis).
• •Expected survival less than 1 years.
• •Female participant is pregnant, lactating, or has a positive screening/baseline pregnancy test.
• •Surgical or medical conditions that, in the opinion of the investigator, could affect the participant's ability to participate in the study, or affect the administration of investigational product, or affect the interpretation of study results, including but not limited to active malignancy, metabolic disease, alcohol or drug abuse, or clinically significant laboratory abnormalities.
• •Presence of serious liver, blood, or immune system disorders as evidenced by the following:
• •1. Acute hepatitis of any cause within the past year.
• •2. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels \> 2 times the upper limit of normal (ULN).
• •3. Presence of end-stage liver disease-related manifestations such as ascites or hepatic encephalopathy.
• •4. Current or anticipated neutropenia (ie, neutrophil count \< 0.5 x 10\^9/L).
• •5. Chemotherapy for cancer, radiation therapy, or potent noncorticosteroid immunosuppressants (eg, cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc) within the past 3 months or corticosteroids (≥ 40 mg prednisone/day) for more than 14 days within 30 days prior to randomization.
• •Positive AIDS antibody screening.
• •History or evidence of severe renal disease or creatinine clearance \< 30 mL/min based on the Cockcroft-Gault formula.
• •Treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
• •Participants who, in the opinion of the investigator, were unable to comply with the protocol and study drug administration procedures or complete the clinical study.