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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE1
NCT ID
NCT07488897

Trial Summary

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

Sponsor: RIGImmune Inc.
Participants: ALL
Start: 2026-02-09
Completion: 2027-02
Min Age: 18 Years
Max Age: 65 Years

Eligibility Criteria

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…

Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.

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