Status:

RECRUITING

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

Lead Sponsor:

ENA Respiratory Pty Ltd

Conditions:

Viral Respiratory Infection

Viral Respiratory Illnesses

Eligibility:

All Genders

18-45 years

Phase:

PHASE2

Brief 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 invest...

Detailed Description

Viral respiratory infections are associated with significant morbidity and mortality. The diversity of viruses, along with their propensity for mutation, ignited an interest in host-directed therapies...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 4 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 9 2027

Estimated Enrollment :

1100 Patients enrolled

Trial Details

Trial ID

NCT07222670

Start Date

December 4 2025

End Date

February 9 2027

Last Update

December 15 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Center for Vaccine Development and Global Health (CVD)

Baltimore, Maryland, United States, 21201

2

Naval Medical Research Command (NMRC)

Bethesda, Maryland, United States, 20889

3

Accellacare of Raleigh

Raleigh, North Carolina, United States, 27609

4

Accellacare of Piedmont HealthCare

Statesville, North Carolina, United States, 28625