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
ENA Respiratory Pty Ltd · NCT07222670
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–45 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 1100
- US sites recruiting
- 6
- Study start
- December 4, 2025
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: INNA-051; Placebo
Conditions: Viral Respiratory Infection; Viral Respiratory Illnesses
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- Presence of Type I or Type II diabetes, asthma or other chronic respiratory condition.
- History of Human Immunodeficiency (HIV), any history of replicating Hepatitis B, and any history of untreated, active Hepatitis C.
- Receipt of investigational product within 90 days or 5 half-lives of the product, whichever is longer.
- Active clinical signs or symptoms of acute respiratory illness (runny nose, sore throat, fever, etc.).
- Received a vaccine against Respiratory Syncytial Virus (RSV) within 90 days.
- Pregnant or lactating women.
Recruiting US locations
Center for Vaccine Development and Global Health (CVD)
Baltimore, MD 21201
Naval Medical Research Command (NMRC)
Bethesda, MD 20889
University Health Center at the University of Maryland
College Park, MD 20742
Accellacare of Raleigh
Raleigh, NC 27609
Accellacare of Piedmont HealthCare
Statesville, NC 28625
Accellacare - Wilmington
Wilmington, NC 20841
Study contacts (from the official record)
- ENA Respiratory · clinicaltrials@enarespiratory.com
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