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Looking for participantsPhase1/Phase2

RIG 101 Trial in Healthy Adults and Adults With Asthma

Sponsor: RIGImmune Inc.

NCT ID: NCT07488897

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
RIG-101 (drug), Placebo (other)
How long the study runs
Study runs about 12 months (dates as stated)
About the drug or intervention
RIG-101 — drug: Single, and repeat escalating intranasal administrations of RIG-101 · Placebo — other: Single and repeat Intranasal administrations
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
82
Started
2026-02-09
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy adult participants
  • • Phase1/Phase2 - 82 participants
  • • Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with healthy adult participants

Where?

  • • London - Virtus Respiratory Research Ltd
  • • Manchester - Medicines Evaluation Unit

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Healthy Adult ParticipantsAsthma ExacerbationSafety and Efficacy

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

Biomarkers mentioned

either a positive

Treatment history

Treatments you must have had:

  • ✓ a written informed consent obtained
  • ✓ a clinical diagnosis of asthma
  • ✓ a pre-bronchodilator FEV1 ≥65% predicted at screening
  • ✓ an ACQ-6 score of \> 0

What the study is looking for

  • ✓Participants must meet all the following inclusion criteria to be eligible to participate in the trial.
  • ✓Participants must have a written agreement to take part obtained prior to any trial related procedure
  • ✓Male and female participants aged between 18 to 65 years inclusive, at the time of agreement to take part.
  • ✓Additional Inclusion Criteria for Healthy Participants
  • ✓\- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1...

Who cannot take part

  • ✗Exclusion Criteria for all Participants
  • ✗Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere...
  • ✗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.
See the full 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 Is This Study? (2 UK sites)

Virtus Respiratory Research Ltd

London, United Kingdom

Recruiting
Site contact (verified)

Medicines Evaluation Unit

Manchester M23 9QZ, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2026-09