RIG 101 Trial in Healthy Adults and Adults With Asthma

NCT07488897 | Recruiting Phase 1

• 1 other identifier: RIG_IN_001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Adult Participants; Asthma Exacerbation; Safety and Efficacy

Outcome Measures

Primary Outcomes (12)

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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.

  Day 1-35

• Systolic/Diastolic blood pressure

  Systolic/Diastolic blood pressure will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline mmHg

  Day 0 - 35

• Physical examinations

  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

  Day 0 -35

• Nasal examinations

  Nasal examinations are performed to identify structural anomalies, inflammation, or other abnormalities in the anterior nares. Unit of Measure: Incidence of nasal exam abnormalities

  Day 0 - 35

• Spirometry (FEV₁ and FVC)

  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

  Day 0-35

• Triplicate 12-lead ECGs and single 12-lead ECGs

  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

  Day 0 - 35

• Safety laboratory testing-haematology

  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

  Day 0 - 35

• Safety laboratory testing-Serum Chemistry

  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

  Day 0- 35

• Safety laboratory testing-Coagulation

  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

  Day 0 -35

• Lower respiratory tract symptom score assessments

  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

  Day -7 to 35

• AUC of Lower respiratory tract symptom score

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

  Day -7 to 35

• Vital Signs - heart rate

  Heart rate will be measured after participants rest in a supine position for ≥5 minutes. Unit of Measure: Change from baseline BPM

  Day 0 - 35

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

RIG-101

EXPERIMENTAL

Drug: RIG-101

Interventions

RIG-101 DRUG

Single, and repeat escalating intranasal administrations of RIG-101

RIG-101

Placebo OTHER

Single and repeat Intranasal administrations

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- Participants must have a pre-bronchodilator FEV1 ≥80% predicted (using GLI Global predicted values17) and an FEV1 / FVC ratio of \>70% absolute at screening.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• RIGImmune Inc.: lead
• Virtus Respiratory Research: collaborator
• Medicines Evaluation Unit Ltd: collaborator

Study Sites (2)

Virtus Respiratory Research Ltd

London, United Kingdom

NOT YET RECRUITING

Medicines Evaluation Unit

Manchester, M23 9QZ, United Kingdom

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 23, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

GB (2)