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].

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

Study Overview

• Status: Recruiting
• Conditions: Asthma Exacerbation; Safety and Efficacy; Healthy Adult Participants
• Intervention / Treatment: Other: Placebo; Drug: RIG-101

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Virtus Respiratory Research Ltd
    • Contact: VirTus Team; Phone Number: 02075545858; Email: volunteer@virtus-rr.com
  • Manchester, United Kingdom, M23 9QZ
    • Recruiting
    • Medicines Evaluation Unit
    • Contact: MEU team; Phone Number: 0800 655 6553; Email: recruitment@meu.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Single and repeat Intranasal administrations
Experimental: RIG-101	Drug: RIG-101; Single, and repeat escalating intranasal administrations of RIG-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RIGImmune Inc.
• Collaborators: Medicines Evaluation Unit Ltd; Virtus Respiratory Research

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RIG_IN_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No