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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229510
• Other study ID #: BHC-RIB-5101
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2021
• Est. completion date: July 12, 2021

Study information

• Verified date: January 2022
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 12, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 50 mg/mL Virazole Inhalant Product
50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
• 100 mg/mL Virazole Inhalant Product
100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
• Placebo
Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted

Locations

Country	Name	City	State
Canada	Bausch Site 1	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with treatment-emergent adverse events (TEAEs)		40 days