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

NCT05229510 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BHC-RIB-5101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with treatment-emergent adverse events (TEAEs)

  40 days

Study Arms (5)

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

Drug: Placebo

Interventions

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); 50 mg/mL Virazole (20 ml total volume)

100 mg/mL Virazole Inhalant Product DRUG

100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted

100 mg/mL Virazole (10 ml total volume); 100 mg/mL Virazole (20 ml total volume)

Placebo DRUG

Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Bausch Site 1

Mississauga, Ontario, L4W 1A4, Canada

Location

Study Officials

• Anya Loncaric

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 8, 2022
• Study Start: March 12, 2021
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)