HealthyPhase 1NCT05229510
Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
A Phase 1 study testing 50 mg/mL Virazole Inhalant Product and 100 mg/mL Virazole Inhalant Product in people with Healthy, run by Bausch Health Americas, Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 50 mg/mL Virazole Inhalant Product and 100 mg/mL Virazole Inhalant Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2021to 12 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
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
- Being tested
- 50 mg/mL Virazole Inhalant Product, 100 mg/mL Virazole Inhalant Product, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg/mL Virazole Inhalant ProductDrug
50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
100 mg/mL Virazole Inhalant ProductDrug
100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted
PlaceboDrug
Placebo (10 or 20 ml total volume) aerosolized and administered until solution depleted
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: 100 mg/mL Virazole Inhalant Product |
| Placebo | Placebo comparator | Placebo aerosolized and administered until solution depleted Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with treatment-emergent adverse events (TEAEs)
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start12 Mar 2021
- Primary completion12 Jul 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229510
- Sponsor's protocol ID
- BHC-RIB-5101
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05229510
- Acronym / sponsor ID
- BHC-RIB-5101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 50 mg/mL Virazole (10 ml total volume) | Experimental | Drug: 50 mg/mL Virazole Inhalant Product50 mg/mL Virazole (10 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 20 minutes). |
| 50 mg/mL Virazole (20 ml total volume) | Experimental | Drug: 50 mg/mL Virazole Inhalant Product50 mg/mL Virazole (20 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 40 minutes). |
| 100 mg/mL Virazole (10 ml total volume) | Experimental | Drug: 100 mg/mL Virazole Inhalant Product100 mg/mL Virazole (10 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 20 minutes). |
| 100 mg/mL Virazole (20 ml total volume) | Experimental | Drug: 100 mg/mL Virazole Inhalant Product100 mg/mL Virazole (20 ml total volume) aerosolized and administered until solution depleted (approximate time of treatment is 40 minutes). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo aerosolized and administered until solution depleted |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg/mL Virazole Inhalant Product50 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted | Drug | 50 mg/mL Virazole (10 ml total volume), 50 mg/mL Virazole (20 ml total volume) |
| 100 mg/mL Virazole Inhalant Product100 mg/mL Virazole (10 or 20 ml total volume) aerosolized and administered until solution depleted | Drug | 100 mg/mL Virazole (10 ml total volume), 100 mg/mL Virazole (20 ml total volume) |
| PlaceboPlacebo (10 or 20 ml total volume) aerosolized and administered until solution depleted | Drug | Placebo |
Primary outcome
Percentage of participants with treatment-emergent adverse events (TEAEs)
Time frame: 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anya Loncaric study director
Bausch Health Americas, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 mg/mL Virazole Inhalant Product and 100 mg/mL Virazole Inhalant Product in people with Healthy, run by Bausch Health Americas, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with treatment-emergent adverse events (TEAEs) (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.