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.
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
- Conditions the study is for
- Viral Respiratory Infection, Viral Respiratory Illnesses
- 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
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
6 sites in 1 country
United States6 sites, 6 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| INNA-051 | Experimental | Not described Receives: Drug: INNA-051 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 8 weeks
Part A - Percentage of Participants with TEAEs
Measured: Up to 8 weeks
Part A - Number of participants with Serious Adverse Events (SAEs)
Measured: Up to 8 weeks
Part A - Percentage of Participants with SAEs
Measured: Up to 8 weeks
Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
Measured: Up to 4 weeks
Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
Measured: Up to 4 weeks
Part A - Change in White Blood Cell Count from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Platelet Count from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Hemoglobin from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Alanine Transaminase (ALT) from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Bilirubin (Total) from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Bilirubin (Direct) from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Alkaline Phosphatase (ALP) from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in Creatinine from Baseline
Measured: Baseline up to 4 weeks
Part A - Change in High Sensitivity C-reactive Protein from Baseline
Measured: Baseline up to 4 weeks
Part B - Number of Participants with TEAEs
Measured: Up to 16 weeks
Part B - Percentage of Participants with TEAEs
Measured: Up to 16 weeks
Part B - Number of Participants with SAEs
Measured: Up to 16 weeks
Part B - Percentage of Participants with SAEs
Measured: Up to 16 weeks
Part B - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
Measured: Up to 12 weeks
Part B - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
Measured: Up to 12 weeks
Part B - Change in White Blood Cell Count from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in Platelet Count from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in Hemoglobin from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in ALT from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in Bilirubin (Total) from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in Bilirubin (Direct) from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in ALP from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in Creatinine from Baseline
Measured: Baseline up to 12 weeks
Part B - Change in High Sensitivity C-reactive Protein from Baseline
Measured: Baseline up to 12 weeks
Part B - Number of Participants with Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR)-confirmed Symptomatic Viral Respiratory Infections
Measured: 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
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)
Part B - Number of Participants With RT-qPCR-confirmed Symptomatic Viral Respiratory Infections by Pathogen
Measured: Up to 12 weeks
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
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
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
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.
- First posted30 Oct 2025
- Study start4 Dec 2025
- Primary completion12 Mar 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ENA Respiratory Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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