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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: ENA Respiratory Pty Ltd • ClinicalTrials.gov ID: NCT07222670

Registry updated: 2026-10-16
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Description

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.

Interventions

  • INNA-051 (Drug)
    powder nasal spray.
  • Placebo (Other)
    powder nasal spray.

Eligibility 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.

Conditions

Viral Respiratory Infection Viral Respiratory Illnesses

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record