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Viral Respiratory InfectionPhase 2POSITSNCT07222670

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

A Phase 2 study testing INNA-051 in people with Viral Respiratory Infection and Viral Respiratory Illnesses, run by ENA Respiratory Pty Ltd at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
INNA-051
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,100 participants
Where
6 sitesUnited States
Study dates
4 Dec 2025to 9 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

ENA Respiratory contact

clinicaltrials@enarespiratory.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • Center for Vaccine Development and Global Health (CVD)

    Baltimore, Maryland, 21201

    Recruiting

  • Naval Medical Research Command (NMRC)

    Bethesda, Maryland, 20889

    Recruiting

  • University Health Center at the University of Maryland

    College Park, Maryland, 20742

    Recruiting

  • Accellacare of Raleigh

    Raleigh, North Carolina, 27609

    Recruiting

  • Accellacare of Piedmont HealthCare

    Statesville, North Carolina, 28625

    Recruiting

  • Accellacare - Wilmington

    Wilmington, North Carolina, 20841

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Viral respiratory infections are associated with significant morbidity and mortality. The diversity of viruses, along with their propensity for mutation, ignited an interest in host-directed therapies that are effective across a wide range of viral pathogens. Toll-like receptors (TLRs) are potential targets for the development of such agents given their central role in host immune defenses.

INNA-051, a TLR2/6 agonist, is being developed as an intranasal innate immune-boosting prophylactic approach for individuals at risk for symptoms and/or complications resulting from respiratory viral infections due to age, occupation, and/or co-morbidities.

This randomized, double-blind, two-part, placebo-controlled, multicenter, Phase 2a trial is designed to evaluate the safety, tolerability, and efficacy of INNA-051 in generally healthy adult participants (age 18 to 45 years, inclusive) who are at increased risk for exposure to viral respiratory infections.

The primary purpose of Part A of the trial is to assess the safety and tolerability of INNA-051 (bilateral intranasal dry powder) in an outpatient setting compared with placebo. In part A of the trial, INNA-051 will be self-administered once weekly for 4 weeks in an outpatient setting during the respiratory virus season.

The purpose of Part B of the trial is to measure the safety, tolerability, and efficacy of INNA-051 bilateral intranasal dry powder compared with placebo in the prevention of symptomatic clinical illness due to RT-qPCR-confirmed viral respiratory infections. In part B of the trial, INNA-051 will be self-administered once weekly for 12 weeks during the North American respiratory virus season.

Being tested
INNA-051, Placebo
Keywords
Respiratory virus, Viral respiratory infection, Viral respiratory illness, Prophylaxis, Intranasal, Viral respiratory disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INNA-051Drug

    powder nasal spray.

  • PlaceboOther

    powder nasal spray.

Study groups in NCT07222670
Study groupRoleWhat they receive
INNA-051ExperimentalNot described
Receives: Drug: INNA-051
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to 8 weeks

  2. Part A - Percentage of Participants with TEAEs

    Measured: Up to 8 weeks

  3. Part A - Number of participants with Serious Adverse Events (SAEs)

    Measured: Up to 8 weeks

  4. Part A - Percentage of Participants with SAEs

    Measured: Up to 8 weeks

  5. Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

    Measured: Up to 4 weeks

  6. Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

    Measured: Up to 4 weeks

  7. Part A - Change in White Blood Cell Count from Baseline

    Measured: Baseline up to 4 weeks

  8. Part A - Change in Platelet Count from Baseline

    Measured: Baseline up to 4 weeks

  9. Part A - Change in Hemoglobin from Baseline

    Measured: Baseline up to 4 weeks

  10. Part A - Change in Alanine Transaminase (ALT) from Baseline

    Measured: Baseline up to 4 weeks

  11. Part A - Change in Bilirubin (Total) from Baseline

    Measured: Baseline up to 4 weeks

  12. Part A - Change in Bilirubin (Direct) from Baseline

    Measured: Baseline up to 4 weeks

  13. Part A - Change in Alkaline Phosphatase (ALP) from Baseline

    Measured: Baseline up to 4 weeks

  14. Part A - Change in Creatinine from Baseline

    Measured: Baseline up to 4 weeks

  15. Part A - Change in High Sensitivity C-reactive Protein from Baseline

    Measured: Baseline up to 4 weeks

  16. Part B - Number of Participants with TEAEs

    Measured: Up to 16 weeks

  17. Part B - Percentage of Participants with TEAEs

    Measured: Up to 16 weeks

  18. Part B - Number of Participants with SAEs

    Measured: Up to 16 weeks

  19. Part B - Percentage of Participants with SAEs

    Measured: Up to 16 weeks

  20. Part B - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

    Measured: Up to 12 weeks

  21. Part B - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)

    Measured: Up to 12 weeks

  22. Part B - Change in White Blood Cell Count from Baseline

    Measured: Baseline up to 12 weeks

  23. Part B - Change in Platelet Count from Baseline

    Measured: Baseline up to 12 weeks

  24. Part B - Change in Hemoglobin from Baseline

    Measured: Baseline up to 12 weeks

  25. Part B - Change in ALT from Baseline

    Measured: Baseline up to 12 weeks

  26. Part B - Change in Bilirubin (Total) from Baseline

    Measured: Baseline up to 12 weeks

  27. Part B - Change in Bilirubin (Direct) from Baseline

    Measured: Baseline up to 12 weeks

  28. Part B - Change in ALP from Baseline

    Measured: Baseline up to 12 weeks

  29. Part B - Change in Creatinine from Baseline

    Measured: Baseline up to 12 weeks

  30. Part B - Change in High Sensitivity C-reactive Protein from Baseline

    Measured: Baseline up to 12 weeks

  31. Part B - Number of Participants with Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR)-confirmed Symptomatic Viral Respiratory Infections

    Measured: Up to 12 weeks

  32. 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

    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.

    Measured: Up to 12 weeks

Secondary outcomes (5)

  1. Part B - Number of Participants With RT-qPCR-confirmed Symptomatic Viral Respiratory Infections by Pathogen

    Measured: Up to 12 weeks

  2. Part B - AUC of the Total Respiratory and Systemic Symptom Scores for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections by Pathogen

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

    Measured: Up to 12 weeks

  3. Part B - Time to Symptom Resolution in Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections

    Time to symptom resolution in participants with RT-qPCR-confirmed symptomatic viral respiratory infections will be measured using the RiiQ.

    Measured: Up to 12 weeks

  4. Part B - Duration of Infection for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections

    Duration of Infection for participants with RT-qPCR-confirmed symptomatic viral respiratory infections as assessed by time to undetectable viral load measured by RT-qPCR.

    Measured: Up to 12 weeks

  5. Part B - Activities of Daily Living in Participants who have RT-qPCR-Confirmed Symptomatic Viral Respiratory Infections (assessed by EuroQol 5-Dimensions 5-Levels questionnaire [EQ-5D-5L])

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2025
  2. Study start4 Dec 2025
  3. Primary completion12 Mar 2027 (estimated)
  4. Study completion9 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07222670
Sponsor's protocol ID
INNA-051-POC-001
Acronym
POSITS
Status last verified
Oct 2026
First submitted
28 Oct 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INNA-051 in people with Viral Respiratory Infection and Viral Respiratory Illnesses, run by ENA Respiratory Pty Ltd at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ENA Respiratory (clinicaltrials@enarespiratory.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 8 weeks). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07222670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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