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Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty
Phase 1
Waitlist Available
Research Sponsored by TenNor Therapeutics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day2, day7, day14
Awards & highlights
No Placebo-Only Group
Summary
This trial uses TNP-2092, given through an IV drip, to study its spread in joint tissues and safety in adults having hip or knee replacement surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day2, day7, day14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day2, day7, day14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Concentration of TNP-2092 in bone
Concentration of TNP-2092 in synovial fluid
Secondary study objectives
Plasma PK of a single IV dose of TNP-2092
Rate of adverse event with TNP-2092
Side effects data
From 2020 Phase 2 trial • 120 Patients • NCT0396449315%
Nausea
9%
Cellulitis
8%
Vomiting
3%
Wound infection
1%
MRSA bacteremia and worsening cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TNP-2092
Vancomycin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TNP-2092 300mg IVExperimental Treatment1 Intervention
TNP-2092 for injection 100mg/vial, 300mg, BID, 1 dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TNP-2092
2016
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
TenNor Therapeutics LimitedLead Sponsor
2 Previous Clinical Trials
126 Total Patients Enrolled