Safety, Tolerability, and Pharmacokinetics of Inhaled Vir... | NCT05229510

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
50 mg/mL Virazole Inhalant Product	Drug	50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted	50 mg/mL Virazole (10 ml total volume)

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

Eligibility Module

Eligibility 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.
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