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 range

18 Years – 45 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 45 Years

Sex

ALL

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