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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

Who can join

Ages 18 to 45 · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• INNA-051 (drug)
• Placebo (other)

Sponsor: ENA Respiratory Pty Ltd · Participants: 1,100 · Started: Dec 4, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07222670

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.