RIG-101 for healthy adults and people with asthma
A Two-part Randomized, Double-blind Placebo Controlled Trial to Assess the Safety and Tolerability of Single and Repeat Ascending Intranasal Doses of RIG-101 in Healthy Participants Followed by Repeat Daily Administration in Adult Participants With Asthma [Part A] Followed by a Randomized Double-blind Placebo Controlled Part to Assess the Efficacy and Safety of RIG-101 in Adult Participants With Asthma Before and After Viral Challenge With Human Rhinovirus RV-A16 [Part B].
This trial will test whether RIG-101 is safe, well tolerated, and can protect healthy adults and adults with asthma from a controlled viral exposure.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RIGImmune Inc. Industry-sponsored |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT07488897 on ClinicalTrials.gov |
What this trial studies
This nested Phase 1–2 study gives RIG-101 or placebo to cohorts of healthy adults and adults with diagnosed asthma to measure safety and tolerability and to test protection against a controlled respiratory viral challenge. After dosing, participants will undergo a standardized experimental viral challenge to compare viral replication, symptom burden, and asthma exacerbations between RIG-101 and placebo groups. Primary outcomes focus on safety and tolerability, with exploratory virologic and clinical endpoints such as viral load, symptom scores, and exacerbation rates in the asthma cohort. The study is conducted at clinical research units in London and Manchester under sponsorship from RIGImmune with local investigator oversight.
Who should consider this trial
Good fit: Adults aged 18–65 who are either in good general health or have a physician diagnosis of asthma with preserved lung function and who are willing to undergo clinic visits and a controlled viral challenge are ideal candidates.
Not a fit: Children, adults over 65, people with uncontrolled or severe asthma, pregnant people, those with significant comorbidities, or anyone unwilling to undergo a viral challenge are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, RIG-101 could reduce the risk or severity of virus-triggered respiratory illness and asthma exacerbations and offer a new preventive option for at-risk adults.
How similar studies have performed: Human experimental viral challenge studies and early-phase immune therapies for respiratory viruses have shown proof-of-concept for protection and symptom reduction, but RIG-101 is a novel agent that has not yet been proven in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must meet all the following inclusion criteria 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. Additional Inclusion Criteria for Healthy Participants \- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1 / FVC ratio of \>70% absolute at screening. Additional Inclusion Criteria for Participants with Asthma * 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 screening. * 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 months prior to randomization to control their asthma. Part B only * 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: 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 interfere with the participants ability to successfully conduct the trial, as judged by the Investigator. * 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 for asthma within 3 months of randomization. * 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 Lymphopoietin * 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
Where this trial is running
London and 1 other locations
- Virtus Respiratory Research Ltd — London, United Kingdom (Not_yet_recruiting)
- Medicines Evaluation Unit — Manchester, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.