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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
Sponsor: ENA Respiratory Pty Ltd
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 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
1100
Start Date
2025-12-04
Completion Date
2027-02-09
Last Updated
2026-02-11
Healthy Volunteers
Yes
Interventions
INNA-051
powder nasal spray.
Placebo
powder nasal spray.
Locations (5)
Center for Vaccine Development and Global Health (CVD)
Baltimore, Maryland, United States
Naval Medical Research Command (NMRC)
Bethesda, 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