drugset
drugset / Trial / NCT05229510

Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers

NCT05229510 ↗

Phase 1 Completed 32 enrolled Bausch Health Americas, Inc.
RandomizedSequentialDouble-blindTreatment

Summary

This study is a Phase 1a, randomized, double-blind, placebo-controlled, safety, tolerability, and PK study in healthy adult volunteers. Participants were screened for eligibility within 14 days prior to enrollment. Four successive cohorts were enrolled, with each cohort receiving a single dose of Virazole or placebo using different delivery regimens.

Timeline

Start
2021-03-12
Primary completion
2021-07-12
Completion
2021-07-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 50 mg/ml Inhaled
Subject Ribavirin Small molecule 100 mg/ml Inhaled

Indications

No indication recorded.