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INNA-051 for Preventing Viral Respiratory Illnesses

This study is testing a powder nasal spray called INNA-051 to see if it can safely and effectively prevent respiratory illnesses caused by viruses. Researchers want to know if INNA-051 can reduce how often you get sick, how severe your illness is, or how long it lasts. You might be able to join if you are a healthy adult between 18 and 45 years old and are at a higher risk of being exposed to viral respiratory infections, for example, due to where you live or your job. The study will compare INNA-051 to a placebo (an inactive powder nasal spray) and will look at any side effects you might experience.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either INNA-051 or a placebo, and neither you nor the study team will know which you are receiving. The study plans to enroll about 1100 healthy adults.
What's involved
You would receive INNA-051 or placebo as a nasal spray once a week for either 4 weeks (Part A) or 12 weeks (Part B) during the respiratory virus season.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 8 weeks after starting treatment in Part A of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 18–45InterventionalPrevention
ENA Respiratory Pty Ltd
~1,100 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:INNA-051Placebo

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured over Up to 8 weeks
+31 more outcomes measured

Conditions

Viral Respiratory Infection
Viral Respiratory Illnesses

Explore related trials

Viral respiratory infection

Where it's being run

5 sites across 2 states
North Carolina3
Maryland2

Who to contact

ENA Respiratory
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)Up to 8 weeks
  • Part A - Percentage of Participants with TEAEsUp to 8 weeks
  • Part A - Number of participants with Serious Adverse Events (SAEs)Up to 8 weeks
  • Part A - Percentage of Participants with SAEsUp to 8 weeks
  • Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)Up to 4 weeks
  • Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)Up to 4 weeks
  • Part A - Change in White Blood Cell Count from BaselineBaseline up to 4 weeks
  • Part A - Change in Platelet Count from BaselineBaseline up to 4 weeks
  • Part A - Change in Hemoglobin from BaselineBaseline up to 4 weeks
  • Part A - Change in Alanine Transaminase (ALT) from BaselineBaseline up to 4 weeks
  • Part A - Change in Bilirubin (Total) from BaselineBaseline up to 4 weeks
  • Part A - Change in Bilirubin (Direct) from BaselineBaseline up to 4 weeks
  • Part A - Change in Alkaline Phosphatase (ALP) from BaselineBaseline up to 4 weeks
  • Part A - Change in Creatinine from BaselineBaseline up to 4 weeks
  • Part A - Change in High Sensitivity C-reactive Protein from BaselineBaseline up to 4 weeks
  • Part B - Number of Participants with TEAEsUp to 16 weeks
  • Part B - Percentage of Participants with TEAEsUp to 16 weeks
  • Part B - Number of Participants with SAEsUp to 16 weeks
  • Part B - Percentage of Participants with SAEsUp to 16 weeks
  • Part B - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)Up to 12 weeks
  • Part B - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)Up to 12 weeks
  • Part B - Change in White Blood Cell Count from BaselineBaseline up to 12 weeks
  • Part B - Change in Platelet Count from BaselineBaseline up to 12 weeks
  • Part B - Change in Hemoglobin from BaselineBaseline up to 12 weeks
  • Part B - Change in ALT from BaselineBaseline up to 12 weeks
  • Part B - Change in Bilirubin (Total) from BaselineBaseline up to 12 weeks
  • Part B - Change in Bilirubin (Direct) from BaselineBaseline up to 12 weeks
  • Part B - Change in ALP from BaselineBaseline up to 12 weeks
  • Part B - Change in Creatinine from BaselineBaseline up to 12 weeks
  • Part B - Change in High Sensitivity C-reactive Protein from BaselineBaseline up to 12 weeks
  • Part B - Number of Participants with Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR)-confirmed Symptomatic Viral Respiratory InfectionsUp to 12 weeks
  • Part B - Area Under the Curve (AUC) of the Total Respiratory and Systemic Symptom Scores for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory InfectionsUp to 12 weeks

    The AUC of the total respiratory and systemic symptom scores will be assessed using the respiratory infection intensity and impact questionnaire (RiiQ) for participants with RT-qPCR-confirmed symptomatic viral respiratory infections.