Actively Recruiting
RIG 101 Trial in Healthy Adults and Adults With Asthma
Led by RIGImmune Inc. · Updated on 2026-03-23
82
Participants Needed
2
Research Sites
51 weeks
Total Duration
On this page
Sponsors
R
RIGImmune Inc.
Lead Sponsor
V
Virtus Respiratory Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
CONDITIONS
Official Title
RIG 101 Trial in Healthy Adults and Adults With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged between 18 to 65 years inclusive
- Written informed consent obtained before any trial procedure
- Good health based on medical history, physical exam, vital signs, ECG, and lab tests at screening
- For healthy participants: pre-bronchodilator FEV1 at least 80% predicted and FEV1/FVC ratio greater than 70% at screening
- For asthma participants: clinical diagnosis of asthma
- For asthma participants: positive skin prick test with wheal diameter ≥3mm or blood eosinophil count >200 cells/µL or FeNO level >25 ppb at screening
- For asthma participants: pre-bronchodilator FEV1 at least 65% predicted at screening
- For asthma participants: using SABA alone or inhaled corticosteroids with SABA or ICS with formoterol as reliever therapy, and/or stable low to mid-dose ICS with or without LABA for at least 3 months before randomization
- For Part B asthma participants: ACQ-6 score greater than 0.75 at screening
- For Part B asthma participants: history of asthma worsening due to cold or respiratory infection in past 2 years
- For Part B asthma participants: seronegativity to RV-A16
You will not qualify if you...
- Any acute or chronic medical or psychiatric condition that may risk safety or interfere with trial participation
- Significant abnormalities altering nose or nasopharynx anatomy that may affect the trial
- History of large nosebleeds within 3 months before first dose or hospitalization due to nosebleeds
- Nasal or sinus surgery within 3 months before first dose
- Signs of upper respiratory tract infection within 6 weeks before screening or dosing
- Current or past use of tobacco, nicotine products, or e-cigarettes within past 6 months
- Smoking history exceeding 5 pack years
- For asthma participants: asthma exacerbation requiring oral/systemic corticosteroids within 8 weeks before randomization or hospitalization within 3 months
- Difficult-to-treat or severe asthma requiring maintenance biologic treatments targeting Type 2 inflammation
- History of life-threatening asthma requiring high-dependency or intensive care
- Close contact with at-risk patient groups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Virtus Respiratory Research Ltd
London, United Kingdom
Not Yet Recruiting
2
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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