RIG 101 Trial in Healthy Adults and Adults 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].

RIG 101 Trial in Healthy Adults and Adults With Asthma (NCT07488897) is a Phase 1 / Phase 2 interventional studying Healthy Adult Participants and Asthma Exacerbation, sponsored by RIGImmune Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Healthy Adult Participants, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 82 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Healthy Adult Participants subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Participants must meet all the following inclusion criteria to be eligible to participate in the trial. - Participants must have a written willing to sign a consent form obtained prior to any trial related procedure - Male and female participants aged between 18 to 65 years inclusive, at the time of willing to sign a consent form. - 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 Who Should NOT Join This Trial: Exclusion Criteria for all Participants ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

RIG-101

Single, and repeat escalating intranasal administrations of RIG-101

OTHER

Placebo

Single and repeat Intranasal administrations

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Virtus Respiratory Research Ltd

London, United Kingdom

Medicines Evaluation Unit

Manchester, United Kingdom

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07488897), the sponsor (RIGImmune Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07488897 clinical trial studying?

Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07488897?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07488897?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07488897. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07488897. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.