Recruiting
Phase 2

INNA-051

Sponsor:

ENA Respiratory Pty Ltd

Code:

NCT07222670

Conditions

Viral Respiratory Infection

Viral Respiratory Illnesses

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

INNA-051

Placebo

Study Details

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.

Conditions

Viral Respiratory Infection

Viral Respiratory Illnesses

Study ID

NCT07222670

Start date

Dec 4, 2025

Status verified date

Feb, 2026

Completion date

Feb 9, 2027

Anticipated

Primary completion date

Feb 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: INNA-051

placebo comparator: Placebo

Interventions

INNA-051

powder nasal spray.

Placebo

powder nasal spray.

Primary outcome measure

  • Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 8 weeks ]
  • Part A - Percentage of Participants with TEAEs [ Time Frame: Up to 8 weeks ]
  • Part A - Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 8 weeks ]
  • Part A - Percentage of Participants with SAEs [ Time Frame: Up to 8 weeks ]
  • Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire) [ Time Frame: Up to 4 weeks ]
  • Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire) [ Time Frame: Up to 4 weeks ]
  • Part A - Change in White Blood Cell Count from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Platelet Count from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Hemoglobin from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Alanine Transaminase (ALT) from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Bilirubin (Total) from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Bilirubin (Direct) from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Alkaline Phosphatase (ALP) from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in Creatinine from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part A - Change in High Sensitivity C-reactive Protein from Baseline [ Time Frame: Baseline up to 4 weeks ]
  • Part B - Number of Participants with TEAEs [ Time Frame: Up to 16 weeks ]
  • Part B - Percentage of Participants with TEAEs [ Time Frame: Up to 16 weeks ]
  • Part B - Number of Participants with SAEs [ Time Frame: Up to 16 weeks ]
  • Part B - Percentage of Participants with SAEs [ Time Frame: Up to 16 weeks ]
  • Part B - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire) [ Time Frame: Up to 12 weeks ]
  • Part B - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire) [ Time Frame: Up to 12 weeks ]
  • Part B - Change in White Blood Cell Count from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in Platelet Count from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in Hemoglobin from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in ALT from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in Bilirubin (Total) from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in Bilirubin (Direct) from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in ALP from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in Creatinine from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Change in High Sensitivity C-reactive Protein from Baseline [ Time Frame: Baseline up to 12 weeks ]
  • Part B - Number of Participants with Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR)-confirmed Symptomatic Viral Respiratory Infections [ Time Frame: Up 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 Infections [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

ENA Respiratory

clinicaltrials@enarespiratory.com

Locations

Center for Vaccine Development and Global Health (CVD)

Recruiting

Baltimore, Maryland, United States, 21201

Naval Medical Research Command (NMRC)

Recruiting

Bethesda, Maryland, United States, 20889

Accellacare of Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Accellacare of Piedmont HealthCare

Recruiting

Statesville, North Carolina, United States, 28625

Accellacare - Wilmington

Recruiting

Wilmington, North Carolina, United States, 20841

More Information

Sponsor

ENA Respiratory Pty Ltd

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • Respiratory virus
  • Viral respiratory infection
  • Viral respiratory illness
  • Prophylaxis
  • Intranasal
  • Viral respiratory disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ENA Respiratory Pty Ltd on 2026-02-11.