Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with treatment-emergent adverse events (TEAEs) [40 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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:
-
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.
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Subject willing and able to provide written informed consent.
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Subject has a body mass index (BMI) ≥ 18.50 and < 30.00 kg/m2.
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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
Exclusion Criteria:
-
Subject has a history of hypersensitivity to ribavirin.
-
Subject has a history of asthma, COPD, or bronchospasm.
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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.
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Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drug(s).
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Subject is currently a tobacco smoker or was a tobacco smoker within 6 months of the Baseline Visit.
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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.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch Site 1 | Mississauga | Ontario | Canada | L4W 1A4 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: Anya Loncaric, Bausch Health Americas, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHC-RIB-5101