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
| NCT ID | NCT07222670 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ENA Respiratory Pty Ltd |
| Condition | Viral Respiratory Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2027-02-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,100 participants in total. It began in 2025-12-04 with a primary completion date of 2027-02-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. * 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.
Contact & Investigator
ENA Respiratory
✉ clinicaltrials@enarespiratory.comFrequently Asked Questions
Who can join the NCT07222670 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Viral Respiratory Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07222670 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07222670 currently recruiting?
Yes, NCT07222670 is actively recruiting participants. Contact the research team at clinicaltrials@enarespiratory.com for enrollment information.
Where is the NCT07222670 trial being conducted?
This trial is being conducted at Baltimore, United States, Bethesda, United States, Raleigh, United States, Statesville, United States and 1 additional location.
Who is sponsoring the NCT07222670 clinical trial?
NCT07222670 is sponsored by ENA Respiratory Pty Ltd. The trial plans to enroll 1,100 participants.