RIG 101 Trial in Healthy Adults and Adults With Asthma

RIGImmune Inc.

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Healthy Adult Participants

Asthma Exacerbation

Safety and Efficacy

Treatments

Drug: RIG-101

Other: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07488897

RIG_IN_001

Details and patient eligibility

About

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

Enrollment

82 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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