A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of INNA-051 Nasal Spray for Preventing Respiratory Illness in Healthy Adults 18 to 45 Years at Risk of Viral Infection

What this Trial Is About

Researchers are evaluating INNA-051, an intranasal powder designed to boost the innate immune system, to see if it can safely reduce the occurrence, severity, or duration of respiratory viral infections in generally healthy adults aged 18 to 45 who are at risk of exposure due to their living or work environments. This Phase 2a trial focuses on viral respiratory infections, which are a major health concern worldwide and cause significant illness and death. Toll-like receptors targeted by INNA-051 play a key role in the body's immune defense against viruses. The study has two parts: Part A tests the safety and tolerability of INNA-051 when self-administered once weekly for 4 weeks during the respiratory virus season, compared to placebo. Part B evaluates safety, tolerability, and effectiveness over 12 weeks of weekly INNA-051 use in preventing symptoms from laboratory-confirmed respiratory viral infections. Both parts use a randomized, double-blind, placebo-controlled design, with participants using the nasal spray at home. Participants will be monitored through clinical assessments, questionnaires on nasal symptoms, and laboratory tests including blood counts and liver function over the treatment periods and follow-up weeks. In Part B, researchers will track the number of symptomatic infections confirmed by RT-qPCR, symptom severity scores, time to symptom resolution, infection duration, and quality of daily living. Safety is assessed by recording any adverse events throughout the study, which lasts up to 16 weeks depending on the part enrolled.

A Study Assessing Safety, Tolerability, and Efficacy of INNA-051 in Preventing Respiratory Illness Due to Viral Infections in Healthy Adults 18 to 45 Years of Age