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Recruiting 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

Conditions: Viral Respiratory Infection, Viral Respiratory Illnesses

Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 1100
Sponsor: ENA Respiratory Pty Ltd

Location: Center for Vaccine Development and Global Health (CVD) Baltimore Maryland

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07222670). StuddyBuddy aggregates publicly available trial information.