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Clinical trial Recruiting at 6 sites Phase 2 Interventional Ages 18 to 45

INNA-051 intranasal prophylaxis to prevent viral respiratory illness in healthy adults 18–45.

Official title: A Randomized, Double-Blind, Two-Part, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of INNA-051 as Prophylaxis for Respiratory Tract Illness in Healthy Adults 18 to 45 Years of Age Who Are at Risk for Viral Respiratory Infections

Run by ENA Respiratory Pty Ltd · NCT07222670 · Data updated 2026-11-12

This trial will test whether weekly self-administered INNA-051 nasal powder can prevent or reduce viral respiratory infections in generally healthy adults aged 18–45 who have higher exposure risk.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 45 Years
SexAll
Enrollment1100 (estimated)
SponsorENA Respiratory Pty Ltd
Industry-sponsored
Locations6 sites (Baltimore, Maryland and 5 other locations)
StatusRecruiting
StartedDecember 4, 2025
Main results expectedMarch 12, 2027
Study endsApril 9, 2027
Registry record updatedOctober 16, 2026
Trial IDNCT07222670 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are generally healthy adults aged 18–45 who are at increased risk of exposure (for example, crowded living or high-contact occupations) and who agree to the contraception requirements.

Probably not a fit

People with chronic respiratory diseases (such as asthma), diabetes, active viral infections (HBV, HCV, HIV), or other exclusionary conditions are unlikely to be eligible or to receive benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2a trial tests INNA-051, a TLR2/6 agonist given as a bilateral intranasal dry powder, as a seasonal prophylactic against symptomatic viral respiratory illness. Generally healthy adults aged 18–45 who are at increased risk of exposure are randomized to receive INNA-051 or placebo once weekly for 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season. Part A primarily examines safety and tolerability in an outpatient setting while Part B measures safety, tolerability, and the effect on occurrence, severity, and duration of symptomatic respiratory illness. The multicenter trial uses self-administration, regular monitoring for adverse events, and surveillance for symptomatic infections.

Why it matters

Potential benefit: If successful, INNA-051 could provide a simple, broadly acting intranasal protection that reduces the chance, severity, or duration of viral respiratory illnesses in at-risk adults.

How similar studies have gone: Preclinical studies and early-phase work with intranasal TLR agonists have shown promise in reducing viral replication and symptoms, but large-scale clinical proof of broad-spectrum human protection remains limited.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Center for Vaccine Development and Global Health (CVD)
    Baltimore, Maryland, United States     Recruiting
  • Naval Medical Research Command (NMRC)
    Bethesda, Maryland, United States     Recruiting
  • University Health Center at the University of Maryland
    College Park, Maryland, United States     Recruiting
  • Accellacare of Raleigh
    Raleigh, North Carolina, United States     Recruiting
  • Accellacare of Piedmont HealthCare
    Statesville, North Carolina, United States     Recruiting
  • Accellacare - Wilmington
    Wilmington, North Carolina, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.