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

NCT ID: NCT05229510

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2021-07-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

50 mg/mL Virazole Inhalant Product

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

50 mg/mL Virazole Inhalant Product

Intervention Type: DRUG

50 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 (10 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 20 minutes).

Group Type: EXPERIMENTAL

100 mg/mL Virazole Inhalant Product

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

100 mg/mL Virazole Inhalant Product

Intervention Type: DRUG

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

Placebo

Placebo aerosolized and administered until solution depleted

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

50 mg/mL Virazole Inhalant Product

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

Intervention Type: DRUG

100 mg/mL Virazole Inhalant Product

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subject is a male or female ≥ 18 and ≤65 years of age.

2. 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).

3. For a male subject must be vasectomized with confirmed postvasectomy semen analysis or a male subject with a documented diagnostic of infertility.

4. Subject willing and able to provide written informed consent.

5. Subject has a body mass index (BMI) ≥ 18.50 and < 30.00 kg/m2.

6. 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.

7. Subject has suitable venous access for blood sampling

Exclusion Criteria

1. Subject has a history of hypersensitivity to ribavirin.

2. Subject has a history of asthma, COPD, or bronchospasm.

3. Subject has anemia defined as hemoglobin or RBC <75% of the institutional lower limit of normal for age and gender.

4. 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.

5. Subject is seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), or positive for SARS-CoV-2 at Screening.

6. Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drug(s).

7. Subject is currently a tobacco smoker or was a tobacco smoker within 6 months of the Baseline Visit.

8. 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.

9. 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.

10. Subject has any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Bausch Site 1

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

BHC-RIB-5101

Identifier Type: -

Identifier Source: org_study_id