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

NCT05229510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Anya Loncaric · Bausch Health Americas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-12
Primary Completion
2021-07-12
Completion
2021-07-12
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229510 on ClinicalTrials.gov