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.
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.
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.).
Parallel
INNA-051
Drugpowder nasal spray.
Placebo
Other interventionpowder nasal spray.
Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Part A - Percentage of Participants with TEAEs
Part A - Number of participants with Serious Adverse Events (SAEs)
Part A - Percentage of Participants with SAEs
Part B - Number of Participants With RT-qPCR-confirmed Symptomatic Viral Respiratory Infections by Pathogen
Part B - AUC of the Total Respiratory and Systemic Symptom Scores for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections by Pathogen
The AUC of the total respiratory and systemic symptom scores will be assessed using the RiiQ for participants with RT-qPCR-confirmed symptomatic viral respiratory infections.
Part B - Time to Symptom Resolution in Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections
Time to symptom resolution in participants with RT-qPCR-confirmed symptomatic viral respiratory infections will be measured using the RiiQ.
Part B - Duration of Infection for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections
Duration of Infection for participants with RT-qPCR-confirmed symptomatic viral respiratory infections as assessed by time to undetectable viral load measured by RT-qPCR.
Click on the lead sponsor to view all of their trials.
