drugset / Trial / NCT05717062
Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter,randomized,double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of a continuous rate infusion (CRI) of IV varespladib followed by transition to the oral dosage form, varespladib-methyl, concurrently with SOC, in participants bitten by venomous snakes. Note: Funding Source - FDA-OOPD
Timeline
- Start
- 2023-05-30
- Primary completion
- 2024-11-28
- Completion
- 2025-02-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varespladib | Small molecule | 0.45 mg/kg | Intravenous |
| Subject | Varespladib Methyl | Small molecule | 250 mg | Oral |