An Open-Label Study to Evaluate Tissue Distribution, Plasma Pharmacokinetics, Safety, and Tolerability After a Single Intravenous Dose of TNP-2092 in Adult Participants Undergoing Primary Total Hip or Knee Arthroplasty

PJI001-04

This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.

2021-03-01

2021-12-31

2022-06-29

Completed

Early phase I

13

Inclusion Criteria: Participants are eligible to be included in the study only if all inclusion criteria are met: 1. Male or females, 18 years of age or older 2. Participants who require primary THA or TKA 3. Body mass index (BMI) \>=18 kg/m2 but \<=40 kg/m2 4. Capable of giving signed informed consent Exclusion Criteria: Participants are excluded from the study if any of the following exclusion criteria are met: 1. History or hypersensitivity or intolerability to any of the following drugs: any member of fluoroquinolones, rifamycin, cefazolin or TNP-2092 2. History of known methicillin-resistant Staphylococcus aureus (MRSA) infections 3. Presence of any surgical or medical condition that in the opinion of the principal investigator and the medical monitor that could impact the interpretation of the results of the study; 4. Evidence of significant hepatic, hematologic or immunologic disease; 5. History or evidence of severe renal disease

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 13, 'type': 'ACTUAL'}}

2022-10-19