Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05229510
Start Date
March 12 2021
End Date
July 12 2021
Last Update
February 8 2022
Active Locations (1)
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1
Bausch Site 1
Mississauga, Ontario, Canada, L4W 1A4