Trials / Completed
CompletedNCT03964493
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- TenNor Therapeutics Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
Detailed description
This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TNP-2092 | TNP-2092 100mg/vial |
| DRUG | Vancomycin | Vancomycin 1g/vial |
Timeline
- Start date
- 2019-04-20
- Primary completion
- 2020-09-28
- Completion
- 2020-09-28
- First posted
- 2019-05-28
- Last updated
- 2023-12-01
- Results posted
- 2023-12-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03964493. Inclusion in this directory is not an endorsement.