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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 50 mg/mL Virazole Inhalant Product; Drug: 100 mg/mL Virazole Inhalant Product; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1A4
      • Bausch Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is a male or female ≥ 18 and ≤65 years of age.

2. For a female, must be of non-childbearing potential according to 1 of the following criteria at least 6 months prior to screening:

   • 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).
3. For a male subject must be vasectomized with confirmed postvasectomy semen analysis or a male subject with a documented diagnostic of infertility.
4. Subject willing and able to provide written informed consent.
5. Subject has a body mass index (BMI) ≥ 18.50 and < 30.00 kg/m2.
6. 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.
7. Subject has suitable venous access for blood sampling

Exclusion Criteria:

1. Subject has a history of hypersensitivity to ribavirin.
2. Subject has a history of asthma, COPD, or bronchospasm.
3. Subject has anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for age and gender.
4. 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.
5. Subject is seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), or positive for SARS-CoV-2 at Screening.
6. Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drug(s).
7. Subject is currently a tobacco smoker or was a tobacco smoker within 6 months of the Baseline Visit.
8. 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.
9. 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.
10. Subject has any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mg/mL Virazole (10 ml total volume); 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 (10 or 20 ml total volume) aerosolized and administered until solution depleted
Experimental: 50 mg/mL Virazole (20 ml total volume); 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; 50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
Experimental: 100 mg/mL Virazole (10 ml total volume); 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 (10 or 20 ml total volume) aerosolized and administered until solution depleted
Experimental: 100 mg/mL Virazole (20 ml total volume); 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; 100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
Placebo Comparator: Placebo; Placebo aerosolized and administered until solution depleted	Drug: Placebo; Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with treatment-emergent adverse events (TEAEs)	40 days

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): July 12, 2021
• Study Completion (Actual): July 12, 2021

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: BHC-RIB-5101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes