NCT05229510

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

A Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	50 mg/mL Virazole Inhalant Product	50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
DRUG	100 mg/mL Virazole Inhalant Product	100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
DRUG	Placebo	Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted

Timeline

• Start date: 2021-03-12
• Primary completion: 2021-07-12
• Completion: 2021-07-12
• First posted: 2022-02-08
• Last updated: 2022-02-08

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study