Healthy Adult ParticipantsPhase 1/2NCT07488897
RIG 101 Trial in Healthy Adults and Adults With Asthma
A Phase 1/2 study testing RIG-101 in people with Healthy Adult Participants and Asthma Exacerbation, run by RIGImmune Inc. at 2 sites in United Kingdom.
Trial summary
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Asthma Exacerbation, Safety and Efficacy
- What is being tested?
- RIG-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 9 Feb 2026to Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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 cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Virtus Respiratory Research Ltd
London
VirTus Team, 02075545858, volunteer@virtus-rr.com
- Recruiting
Medicines Evaluation Unit
Manchester, M23 9QZ
MEU team, 0800 655 6553, recruitment@meu.org
About this study
Official 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].
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
- Being tested
- RIG-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIG-101Drug
Single, and repeat escalating intranasal administrations of RIG-101
PlaceboOther
Single and repeat Intranasal administrations
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| RIG-101 | Experimental | Not described Receives: Drug: RIG-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0 - 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start9 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RIGImmune Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virtus Respiratory Research, Medicines Evaluation Unit Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488897
- Sponsor's protocol ID
- RIG_IN_001
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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].
- ClinicalTrials.gov ID
- NCT07488897
- Acronym / sponsor ID
- RIG_IN_001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- RIGImmune Inc.Industry (pharma, biotech, devices)
- Collaborators
- Virtus Respiratory Research, Medicines Evaluation Unit Ltd
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| RIG-101 | Experimental | Drug: RIG-101 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIG-101Single, and repeat escalating intranasal administrations of RIG-101 | Drug | RIG-101 |
| PlaceboSingle and repeat Intranasal administrations | Other | Placebo |
Primary outcome
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.
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RIG-101 in people with Healthy Adult Participants and Asthma Exacerbation, run by RIGImmune Inc. at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1-35). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.