A Two-Part Study of RIG-101 Given as Intranasal Doses in Healthy Adults and Adults With Asthma to Assess Safety, Tolerability, and Effectiveness Against Rhinovirus Infection

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of RIG-101, an investigational drug given intranasally, in both healthy adults and adults with asthma. This trial is a two-part, randomized, double-blind, placebo-controlled study designed to assess how well participants tolerate single and repeated doses of RIG-101 and to test its effect on adults with asthma before and after exposure to a common cold virus called human rhinovirus RV-A16. The study includes a first part where healthy participants receive single and repeated ascending doses of RIG-101 administered through the nose. In the second part, adults with asthma receive repeat daily doses of RIG-101 or placebo followed by a controlled viral challenge. The trial compares RIG-101 to placebo to evaluate safety and potential efficacy. The dosing and monitoring occur over a period of up to 35 days. Participants will undergo various assessments including monitoring for adverse events, blood pressure checks, physical and nasal exams, lung function tests spirometry, heart monitoring via ECG, and laboratory safety tests. Symptom scores related to lower respiratory tract health will be recorded from before treatment through 35 days. The trial will also track vital signs such as heart rate and will include follow-up for safety and tolerability throughout the study period.

RIG 101 Trial in Healthy Adults and Adults With Asthma