drugset / Trial / NCT05717062

Broad-spectrum Rapid Antidote: Varespladib IV to Oral Trial for Snakebite (BRAVIO)

NCT05717062 ↗

Phase 2 Completed 140 enrolled Ophirex, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Varespladib Small molecule 0.45 mg/kg Intravenous
Subject Varespladib Methyl Small molecule 250 mg Oral