Actively Recruiting
A Two-part Randomized, Double-blind Placebo Controlled Trial to Assess Safety and Tolerability of Intranasal Doses of RIG-101 in Healthy Adults and Adults With Asthma, Including Viral Challenge
Led by RIGImmune Inc. · Updated on 2026-03-23
82
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
R
RIGImmune Inc.
Lead Sponsor
V
Virtus Respiratory Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of RIG-101, an investigational drug given intranasally, in both healthy adults and adults with asthma. This trial is a two-part, randomized, double-blind, placebo-controlled study designed to assess how well participants tolerate single and repeated doses of RIG-101 and to test its effect on adults with asthma before and after exposure to a common cold virus called human rhinovirus RV-A16. The study includes a first part where healthy participants receive single and repeated ascending doses of RIG-101 administered through the nose. In the second part, adults with asthma receive repeat daily doses of RIG-101 or placebo followed by a controlled viral challenge. The trial compares RIG-101 to placebo to evaluate safety and potential efficacy. The dosing and monitoring occur over a period of up to 35 days. Participants will undergo various assessments including monitoring for adverse events, blood pressure checks, physical and nasal exams, lung function tests (spirometry), heart monitoring via ECG, and laboratory safety tests. Symptom scores related to lower respiratory tract health will be recorded from before treatment through 35 days. The trial will also track vital signs such as heart rate and will include follow-up for safety and tolerability throughout the study period.
CONDITIONS
Brief Title
RIG 101 Trial in Healthy Adults and Adults With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide written informed consent before any trial procedures
- Male and female participants aged 18 to 65 years inclusive
- Participants must be in good health based on medical history, physical exam, vital signs, ECG, and lab tests
- Healthy participants must have pre-bronchodilator FEV1 at least 80% predicted and FEV1/FVC ratio over 70%
- Participants with asthma must have a clinical diagnosis of asthma
- Asthma participants must show allergy or inflammation markers such as positive skin test, blood eosinophils over 200 cells/µL, or FeNO over 25 ppb
- Asthma participants must have pre-bronchodilator FEV1 at least 65% predicted
- Asthma participants must use SABA alone or with inhaled corticosteroids or formoterol, or stable low to mid-dose ICS with or without LABA for at least 3 months
- For Part B, asthma participants must have ACQ-6 score over 0.75 at screening
- For Part B, asthma participants must report asthma worsening in past 2 years related to cold or respiratory infection
- For Part B, asthma participants must be seronegative to human rhinovirus RV-A16
You will not qualify if you...
- Any acute or chronic medical or psychiatric condition that may risk participant safety or interfere with trial participation
- Significant abnormalities or alterations of the nose or nasopharynx that interfere with the trial
- History of serious nosebleeds within 3 months or previous hospitalization for nosebleeds
- Nasal or sinus surgery within 3 months prior to first study drug administration
- Signs of upper respiratory infection within 6 weeks before screening or first dose
- Current or previous use of tobacco, nicotine, or e-cigarettes in past 6 months
- Smoking history exceeding 5 pack years
- For asthma participants: asthma exacerbations requiring oral/systemic steroids within 8 weeks or hospitalization within 3 months
- Severe or difficult-to-treat asthma requiring biologic therapies
- History of life-threatening asthma needing intensive care
- Close contact with at-risk patient groups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 days
Participants receive single and repeat escalating intranasal administrations of the study drug or placebo while being monitored for safety and tolerability.
Multiple visits during treatment period
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here