Actively Recruiting

Phase 2
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT07222670

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

Led by ENA Respiratory Pty Ltd · Updated on 2026-02-11

1100

Participants Needed

5

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • In good general health without significant medical, psychiatric, chronic, or intermittent conditions
  • At risk for exposure to viral respiratory infection due to living or working conditions such as crowded housing, childcare, healthcare, factory work, public transportation, or education
  • Agree to use highly effective birth control
Not Eligible

You will not qualify if you...

  • Diagnosed with Type I or Type II diabetes, asthma, or other chronic respiratory conditions
  • Have active infections including Hepatitis B, Hepatitis C, or HIV
  • Currently participating in another clinical trial involving investigational products or received such products within the past 90 days or five half-lives
  • Showing active clinical signs or symptoms of acute respiratory illness such as runny nose, sore throat, or fever
  • Received Respiratory Syncytial Virus (RSV) or COVID-19 vaccine within the last 180 days
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Center for Vaccine Development and Global Health (CVD)

Baltimore, Maryland, United States, 21201

Actively Recruiting

2

Naval Medical Research Command (NMRC)

Bethesda, Maryland, United States, 20889

Actively Recruiting

3

Accellacare of Raleigh

Raleigh, North Carolina, United States, 27609

Actively Recruiting

4

Accellacare of Piedmont HealthCare

Statesville, North Carolina, United States, 28625

Actively Recruiting

5

Accellacare - Wilmington

Wilmington, North Carolina, United States, 20841

Actively Recruiting

Loading map...

Research Team

E

ENA Respiratory

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here