RecruitingPhase 2

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

United States1,100 participantsStarted 2025-12-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * 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.

What they're measuring

Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 8 weeks

Part A - Percentage of Participants with TEAEs

Timeframe: Up to 8 weeks

Part A - Number of participants with Serious Adverse Events (SAEs)

Timeframe: Up to 8 weeks

Part A - Percentage of Participants with SAEs

Timeframe: Up to 8 weeks

Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

Timeframe: Up to 4 weeks

Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

Timeframe: Up to 4 weeks

Part A - Change in White Blood Cell Count from Baseline

Timeframe: Baseline up to 4 weeks

Part A - Change in Platelet Count from Baseline

Timeframe: Baseline up to 4 weeks

Trial details

NCT IDNCT07222670

SponsorENA Respiratory Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-09

Contact for this trial

ENA Respiratory

clinicaltrials@enarespiratory.com

View on ClinicalTrials.gov More Viral Respiratory Infection trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 8 weeks

Part A - Percentage of Participants with TEAEs

Timeframe: Up to 8 weeks

Part A - Number of participants with Serious Adverse Events (SAEs)

Timeframe: Up to 8 weeks

Part A - Percentage of Participants with SAEs

Timeframe: Up to 8 weeks

Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

Timeframe: Up to 4 weeks

Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

Timeframe: Up to 4 weeks

Part A - Change in White Blood Cell Count from Baseline

Timeframe: Baseline up to 4 weeks

Part A - Change in Platelet Count from Baseline

Timeframe: Baseline up to 4 weeks