NCT05229510

CompletedPhase 1

Safety, Tolerability, and Pharmacokinetics of Inhaled Virazo...

Bausch Health Americas, Inc.Source

Bausch Health Americas, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BHC-RIB-5101

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

March 12, 2021

Actual (reported)

Primary Completion

July 12, 2021

Actual (reported)

Study Completion

July 12, 2021

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: July 12, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 12, 2021
Actual (reported)
Primary Completion
July 12, 2021
Actual (reported)
Study Completion
July 12, 2021
Actual (reported)
First Submitted
January 28, 2022
Actual (reported)
First Posted
February 8, 2022
Actual (reported)

Last Updated: February 8, 2022
Status Verified: January 2022
Last Update Submitted: January 28, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Percentage of participants with treatment-emergent adverse events (TEAEs)
40 days

Study Arms (5)

50 mg/mL Virazole (10 ml total volume)

EXPERIMENTAL

50 mg/mL Virazole (10 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 20 minutes).

Drug: 50 mg/mL Virazole Inhalant Product

50 mg/mL Virazole (20 ml total volume)

EXPERIMENTAL

50 mg/mL Virazole (20 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 40 minutes).

Drug: 50 mg/mL Virazole Inhalant Product

100 mg/mL Virazole (10 ml total volume)

EXPERIMENTAL

Interventions

50 mg/mL Virazole Inhalant ProductDrug

50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted

50 mg/mL Virazole (10 ml total volume)50 mg/mL Virazole (20 ml total volume)

100 mg/mL Virazole Inhalant ProductDrug

100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject is a male or female ≥ 18 and ≤65 years of age.
For a female, must be of non-childbearing potential according to 1 of the following criteria at least 6 months prior to screening:

Sponsors & Collaborators

Bausch Health Americas, Inc.
Industrylead

Study Sites (1)

Bausch Site 1

Mississauga, Ontario, L4W 1A4, Canada

Study Officials

Anya Loncaric
Bausch Health Americas, Inc.
STUDY DIRECTOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 28, 2022

First Posted

February 8, 2022

Study Start

March 12, 2021

Actual (reported)

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100 mg/mL Virazole (10 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 20 minutes).

Drug: 100 mg/mL Virazole Inhalant Product

100 mg/mL Virazole (20 ml total volume)

EXPERIMENTAL

100 mg/mL Virazole (20 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 40 minutes).

Drug: 100 mg/mL Virazole Inhalant Product

Placebo

PLACEBO COMPARATOR

Placebo aerosolized and administered until solution depleted

Drug: Placebo

100 mg/mL Virazole (10 ml total volume)100 mg/mL Virazole (20 ml total volume)

PlaceboDrug

Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

hysteroscopic sterilization;

bilateral tubal ligation or bilateral salpingectomy;

post-menopausal with spontaneous amenorrhea for ≥ 12 consecutive months with follicle-stimulating hormone \[FSH\] \> 25.8 mIU/mL; or

having had bilateral oophorectomy (with or without hysterectomy).

For a male subject must be vasectomized with confirmed postvasectomy semen analysis or a male subject with a documented diagnostic of infertility.

Subject willing and able to provide written informed consent.

Subject has a body mass index (BMI) ≥ 18.50 and \< 30.00 kg/m2.

Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the Investigator.

Subject has suitable venous access for blood sampling

You may not qualify if:

Subject has a history of hypersensitivity to ribavirin.
Subject has a history of asthma, COPD, or bronchospasm.
Subject has anemia defined as hemoglobin or RBC \<75% of the institutional lower limit of normal for age and gender.
Subject has any major illness or systemic infection (including COVID-19) within 4 weeks of the Screening Visit or has a clinically relevant history or is currently suffering from a disease or condition that, in the opinion of the Investigator, may affect the evaluation of the study drug or place the subjects at undue risk.
Subject is seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), or positive for SARS-CoV-2 at Screening.
Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drug(s).
Subject is currently a tobacco smoker or was a tobacco smoker within 6 months of the Baseline Visit.
Subject has donated 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, Clinical Studies, etc.) in the previous 56 days prior to the Baseline Visit.
Subject is currently participating in any drug or device clinical investigation or has received an investigational agent or approved drug that, in the Investigator's judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit.
Subject has any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study

Contact the study team to confirm eligibility.

Primary Completion

July 12, 2021

Actual (reported)

Study Completion

July 12, 2021

Actual (reported)

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05229510
Data provider: ClinicalTrials.gov
Source updated: 2022-02-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:04 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

50 mg/mL Virazole (10 ml total volume)

50 mg/mL Virazole (20 ml total volume)

100 mg/mL Virazole (10 ml total volume)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

100 mg/mL Virazole (20 ml total volume)

Placebo

You may not qualify if:

Data Sharing

Source record

Locations