Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
NCT04294862 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2022-10-19
Summary
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.
Conditions
- Prosthetic Joint Infection
Interventions
- DRUG
-
TNP-2092
TNP-2092 for injection 100mg/vial
Sponsors & Collaborators
-
TenNor Therapeutics Limited
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-01
- Primary Completion
- 2021-12-31
- Completion
- 2022-06-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage
NCT01605201 ·Status: COMPLETED ·Phase: PHASE1
-
Autologous Chondrocyte Implantation in the Patellofemoral Joint
NCT00212849 ·Status: COMPLETED
-
Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
NCT00436982 ·Status: COMPLETED ·Phase: NA
-
Intraarticular Antibiotic in TKA
NCT04297631 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
NCT03721328 ·Status: COMPLETED ·Phase: PHASE2
-
Intra-articular Vancomycin Powder in Knee and Hip Arthroplasty
NCT04399642 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Prospective, Randomized Parallel Group Study of the Efficacy of Vancomycin Administered Through Intraarticular Injection Versus Intraosseous Injection Versus Intravenous Infusion in Patients Undergoing Total Knee Arthroplasty
NCT07282782 ·Status: RECRUITING ·Phase: PHASE4
-
Hyaluronan in the Treatment of Painful Tendinopathy
NCT01290510 ·Status: COMPLETED ·Phase: NA
-
Cellular Matrix Device for the Treatment of Mild to Moderate Knee Osteoarthritis
NCT03328728 ·Status: UNKNOWN ·Phase: NA
-
Antibiotic Loaded Cement After TKA
NCT05429671 ·Status: COMPLETED ·Phase: PHASE3
-
Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study
NCT01041937 ·Status: COMPLETED ·Phase: NA
-
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial
NCT01003080 ·Status: COMPLETED ·Phase: NA
-
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
NCT04042233 ·Status: COMPLETED ·Phase: PHASE4
-
Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee
NCT00599248 ·Status: COMPLETED ·Phase: PHASE1
-
Study of an All Polyethylene Tibial Component
NCT02540902 ·Status: UNKNOWN ·Phase: NA
-
Safety Study of PTP-001 for Treating Knee Osteoarthritis
NCT04632966 ·Status: UNKNOWN ·Phase: PHASE1
-
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
NCT04238143 ·Status: RECRUITING ·Phase: NA
-
A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation
NCT04432012 ·Status: RECRUITING ·Phase: PHASE4
-
Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee
NCT01221441 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
NCT05526898 ·Status: RECRUITING ·Phase: NA
-
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee
NCT04612023 ·Status: UNKNOWN ·Phase: PHASE2
-
Treatment of Osteoarthritis With the Stromal Vascular Fraction of Abdominal Adipose Tissue - a Pilot Study
NCT02697682 ·Status: COMPLETED ·Phase: NA
-
A Study Evaluating the Efficacy of a Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells in Patients With Knee Osteoarthritis
NCT02838069 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
NCT02170935 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
NCT02183896 ·Status: WITHDRAWN ·Phase: NA