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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Viral Respiratory Infection, Viral Respiratory Illnesses

In brief

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.

Key facts

Study ID

NCT07222670

Run by

ENA Respiratory Pty Ltd

People needed

1100

Starts

2025-12-04

Expected to finish

2027-02-09

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Vaccine Development and Global Health (CVD) — Baltimore, Maryland, United States (enrolling)
• Naval Medical Research Command (NMRC) — Bethesda, Maryland, United States (enrolling)
• Accellacare of Raleigh — Raleigh, North Carolina, United States (enrolling)
• Accellacare of Piedmont HealthCare — Statesville, North Carolina, United States (enrolling)
• Accellacare - Wilmington — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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