ClinicaliQ Trial Snapshot
- RIG 101 Trial in Healthy Adults and Adults With Asthma — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT07488897.
- Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy.
- Sponsor: RIGImmune Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy
Eligibility Snapshot
- : 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.