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

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.
• 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

Exclusion criteria

• 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