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NCT Number: NCT07488897

RIG 101 Trial in Healthy Adults and Adults With Asthma

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

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Key information

Conditions

Healthy Adult Participants Asthma Exacerbation Safety and Efficacy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Virtus Respiratory Research Ltd, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIG-101

Drug

Single, and repeat escalating intranasal administrations of RIG-101

Placebo

Other

Single and repeat Intranasal administrations

Primary outcomes

  1. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1-35

    All adverse events (AEs) and serious adverse events (SAEs) will be collected using standard regulatory AE/SAE monitoring procedures. Events will be assessed for severity and relationship to intranasal RIG-101 according to protocol-defined criteria. Data will be recorded from the signing of informed consent through the follow-up visit.

  2. Systolic/Diastolic blood pressure

    Time frame: Day 0 - 35

    Systolic/Diastolic blood pressure will be measured after participants rest in a supine position for ≥5 minutes.

    Unit of Measure:

    Change from baseline mmHg

  3. Physical examinations

    Time frame: Day 0 -35

    Physical examinations-general and system-specific (cardiovascular, respiratory, ENT, lymphatic, neurological, abdominal, musculoskeletal, dermatologic)-will be performed per protocol. Findings will be categorized as normal or abnormal, with clinical significance determined by the investigator.

    Unit of Measure:

    Incidence of clinically significant physical exam abnormalities

  4. Nasal examinations

    Time frame: Day 0 - 35

    Nasal examinations are performed to identify structural anomalies, inflammation, or other abnormalities in the anterior nares.

    Unit of Measure:

    Incidence of nasal exam abnormalities

  5. Spirometry (FEV₁ and FVC)

    Time frame: Day 0-35

    Spirometry (FEV₁ and FVC) will be conducted per ATS/ERS 2019 standards. Predicted values will use the GLI global dataset.

    Unit of Measure:

    Change from baseline in litres

    Measurement Tool:

    ATS/ERS-compliant spirometers

  6. Triplicate 12-lead ECGs and single 12-lead ECGs

    Time frame: Day 0 - 35

    Triplicate 12-lead ECGs and single 12-lead ECGs will be collected after ≥5 minutes of supine rest. Parameters include HR, PR interval, QRS duration, QT, and QTcF.

    Unit of Measure:

    Change from baseline in ECG parameters

  7. Safety laboratory testing-haematology

    Time frame: Day 0 - 35

    Safety laboratory testing-haematology, will be assessed per protocol and judged for clinical significance.

    Unit of Measure:

    Change in parameters of haematology laboratory values assessed using local lab reference ranges

  8. Safety laboratory testing-Serum Chemistry

    Time frame: Day 0- 35

    Safety laboratory testing-Serum chemistry, will be assessed per protocol and judged for clinical significance.

    Unit of Measure:

    Change in parameters of Serum chemistry laboratory values assessed using local lab reference ranges

  9. Safety laboratory testing-Coagulation

    Time frame: Day 0 -35

    Safety laboratory testing-Coagulation will be assessed per protocol and judged for clinical significance.

    Unit of Measure:

    Change in parameters of Coagulation laboratory values assessed using local lab reference ranges

  10. Lower respiratory tract symptom score assessments

    Time frame: Day -7 to 35

    Participants complete twice-daily LRSS assessments for 35 days. The primary endpoint is the total symptom burden expressed as area under the curve (AUC) for LRSS from baseline through Day 35.

    Unit of Measure:

    AUC (LRSS × days)

    Measurement Tool:

    Twice-daily electronic diary (eDiary) symptom scoring system

  11. AUC of Lower respiratory tract symptom score

    Time frame: Day -7 to 35

    AUC of LRSS where the lower respiratory symptoms are measured for 35 days by twice-daily date and time stamped eDiary collection

  12. Vital Signs - heart rate

    Time frame: Day 0 - 35

    Heart rate will be measured after participants rest in a supine position for ≥5 minutes.

    Unit of Measure: Change from baseline BPM

Sponsors and collaborators

Lead sponsor

RIGImmune Inc.

Industry

Collaborators

  • Medicines Evaluation Unit Ltd
  • Virtus Respiratory Research

Registry information

Official study title

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].

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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