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
A Randomized, Double-Blind, Two-Part, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of INNA-051 as Prophylaxis for Respiratory Tract Illness in Healthy Adults 18 to 45 Years of Age Who Are at Risk for Viral Respiratory Infections
ENA Respiratory Pty Ltd
1,100 participants
Dec 4, 2025
INTERVENTIONAL
Conditions
Summary
Acute upper and lower respiratory infections are a major public health problem and a leading cause of morbidity and mortality worldwide. The purpose of this trial is to assess the safety of the investigational agent INNA-051, given intranasally, and its potential effectiveness in reducing the occurrence, severity, and/or the duration of illness resulting from respiratory virus infections. The trial will enroll generally healthy adults (age 18 - 45 years) who are at risk for exposure to viral respiratory infection, for example, due to living conditions or occupation. Participants will be treated with INNA-051 or placebo once weekly for 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season.
Eligibility
Inclusion Criteria3
- In good general health and without clinically significant medical, psychiatric, chronic or intermittent health conditions.
- At risk for exposure to viral respiratory infection, for example, living in crowded housing, university housing, or military barracks, working in a childcare center or caring for a child aged 10 or less, healthcare workers, factory workers, taxi and bus drivers, grocery clerks, and educators or counselors who work in crowded environments or with multiple exposures with different people daily.
- Agree to use highly effective birth control.
Exclusion Criteria6
- Presence of Type I or Type II diabetes, asthma or other chronic respiratory condition.
- Active infections including Hepatitis B Virus, Hepatitis C Virus, or Human Immunodeficiency (HIV).
- Concurrent participation in another clinical trial involving investigational product or prior receipt of investigational product within 90 days or 5 half-lives of the product.
- Active clinical signs or symptoms of acute respiratory illness (runny nose, sore throat, fever, etc.).
- Received a vaccine against Respiratory Syncytial Virus (RSV) or COVID-19 within 180 days.
- Pregnant or lactating women.
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Interventions
powder nasal spray.
powder nasal spray.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07222670