Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04294862

Enrollment

Registered

2020-03-04

Start date

2021-03-01

Completion date

2022-06-29

Last updated

2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Joint Infection

Keywords

TNP-2092, tissue distribution, THA, TKA, safety, PK

Brief 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.

Detailed description

This is a Phase 1, open-label study to evaluate the tissue distribution, plasma PK, safety, and tolerability after a single 300 mg intravenous (IV) dose of TNP-2092 administered before induction of anesthesia in adult participants undergoing THA or TKA. Sixteen patients who are scheduled to undergo primary THA or TKA will be enrolled. The enrolled participants who meet the inclusion/exclusion criteria will receive the study intervention (a single 300 mg IV dose of TNP-2092) 2 hours before induction of anesthesia on Day 1. Tissue samples from bone and synovial fluid will be collected during surgery and analyzed for TNP-2092 and cefazolin concentrations. Plasma samples will be collected on Day 1 and Day 2 for PK analysis. Safety and tolerability information will be collected on Day 1 and Day 2 at the clinical center, on Day 7 by phone, and on Day 14 at a final follow-up visit.

Interventions

DRUGTNP-2092

TNP-2092 for injection 100mg/vial

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of TNP-2092 in synovial fluid	2 hours after infusion	Concentration in ng/mL
Concentration of TNP-2092 in bone	2 hours after infusion	Concentration in ng/g

Secondary

Measure	Time frame	Description
Plasma PK of a single IV dose of TNP-2092	pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion	CTissue: Drug concentration in tissue, ng/mL
Rate of adverse event with TNP-2092	Day2, Day7, Day14	Description of adverse events as assessed by CTCAE 4.0

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026