BridgeMD
New treatment option for Healthy Adult Participants
Official title RIG 101 Trial in Healthy Adults and Adults With Asthma
ClinicalTrials.gov ID: NCT07488897
What this study is testing
What is RIG-101?
RIG-101 is an investigational medicine, being studied as a potential treatment for healthy adult participants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participants must meet all the following to be eligible to participate in the trial.
- Participants must have a written informed consent obtained prior to any trial related procedure
- Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent.
- Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory...
- Participants must have a clinical diagnosis of asthma.
You likely can't join if
- Exclusion Criteria for all Participants
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety...
- Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the trial at time of...
- Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first administration of IMP and/or history of...
- Any nasal or sinus surgery within 3 months of the first administration of IMP
- Any signs of upper respiratory tract infection within 6 weeks of screening or prior to first administration of IMP
See the full eligibility criteria
- Participants must meet all the following to be eligible to participate in the trial.
- Participants must have a written informed consent obtained prior to any trial related procedure
- Male and female participants aged between 18 to 65 years inclusive, at the time of informed consent.
- Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening, as judged by the Investigator...
- Participants must have a clinical diagnosis of asthma.
- Participants must have either a positive skin prick test with a wheal diameter of ≥3mm greater than control test at 15 minutes, and/or a blood eosinophil count of \> 200 cells / µL and/or a FeNO level of \> 25 ppb at...
- Participants must have a pre-bronchodilator FEV1 ≥65% predicted at screening
- Participants must be using SABA alone or inhaled corticosteroids (ICS) with SABA or ICS with formoterol as reliever therapy, AND/OR regular use of low to mid-dose ICS with or without LABA at a stable dose for at least 3...
- Participants must have an ACQ-6 score of \> 0.75 at screening.
- Participants must have a history of asthma worsening in the previous 2 years, in response to a cold or respiratory infection, as confirmed by the participant.
- Participants must demonstrate seronegativity to RV-A16
- Exclusion Criteria for all Participants
- History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical trial, expose the participant to undue risk or...
- Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the trial at time of screening.
- Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first administration of IMP and/or history of being hospitalized due to epistaxis on any previous occasion.
- Any nasal or sinus surgery within 3 months of the first administration of IMP
- Any signs of upper respiratory tract infection within 6 weeks of screening or prior to first administration of IMP
- Current or previous use of tobacco, nicotine products or e-cigarettes in the past 6 months prior to screening.
- Smoking history of \> 5 pack years. Additional Exclusion Criteria for Participants with Asthma
- Any asthma exacerbation on their current asthma controller medication requiring oral/systemic corticosteroids within 8 weeks of randomization, or that resulted in overnight hospitalization requiring additional treatment...
- Difficult-to-treat or severe asthma requiring the maintenance use of add-on biologic Type 2 targeted treatments including anti-Immunoglobulin E, anti-IL4 receptor, anti-IL5, anti-IL5 receptor, and anti-Thymic Stromal...
- History of life-threatening asthma, defined as any asthma episode that required admission to a high-dependency or intensive therapy unit.
- Individuals with close contact to at risk patient groups
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
- Manchester, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom; Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.