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

NCT07222670 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INNA-051-POC-001
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 5

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

Keywords

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

Outcome Measures

Primary Outcomes (32)

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

  Up to 8 weeks

• Part A - Percentage of Participants with TEAEs

  Up to 8 weeks

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

  Up to 8 weeks

• Part A - Percentage of Participants with SAEs

  Up 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 Baseline

  Baseline up to 4 weeks

• Part A - Change in Platelet Count from Baseline

  Baseline up to 4 weeks

• Part A - Change in Hemoglobin from Baseline

  Baseline up to 4 weeks

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

  Baseline up to 4 weeks

• Part A - Change in Bilirubin (Total) from Baseline

  Baseline up to 4 weeks

• Part A - Change in Bilirubin (Direct) from Baseline

  Baseline up to 4 weeks

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

  Baseline up to 4 weeks

• Part A - Change in Creatinine from Baseline

  Baseline up to 4 weeks

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

  Baseline up to 4 weeks

• Part B - Number of Participants with TEAEs

  Up to 16 weeks

• Part B - Percentage of Participants with TEAEs

  Up to 16 weeks

• Part B - Number of Participants with SAEs

  Up to 16 weeks

• Part B - Percentage of Participants with SAEs

  Up 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 Baseline

  Baseline up to 12 weeks

• Part B - Change in Platelet Count from Baseline

  Baseline up to 12 weeks

• Part B - Change in Hemoglobin from Baseline

  Baseline up to 12 weeks

• Part B - Change in ALT from Baseline

  Baseline up to 12 weeks

• Part B - Change in Bilirubin (Total) from Baseline

  Baseline up to 12 weeks

• Part B - Change in Bilirubin (Direct) from Baseline

  Baseline up to 12 weeks

• Part B - Change in ALP from Baseline

  Baseline up to 12 weeks

• Part B - Change in Creatinine from Baseline

  Baseline up to 12 weeks

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

  Baseline up to 12 weeks

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

  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.

  Up to 12 weeks

Secondary Outcomes (5)

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

  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

  Up to 12 weeks

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

  Up to 12 weeks

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

  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])

  Up to 12 weeks

Study Arms (2)

INNA-051

EXPERIMENTAL

Drug: INNA-051

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

INNA-051 DRUG

powder nasal spray.

INNA-051

Placebo OTHER

powder nasal spray.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ENA Respiratory Pty Ltd: lead

Study Sites (5)

Center for Vaccine Development and Global Health (CVD)

Baltimore, Maryland, 21201, United States

RECRUITING

Naval Medical Research Command (NMRC)

Bethesda, Maryland, 20889, United States

RECRUITING

Accellacare of Raleigh

Raleigh, North Carolina, 27609, United States

RECRUITING

Accellacare of Piedmont HealthCare

Statesville, North Carolina, 28625, United States

RECRUITING

Accellacare - Wilmington

Wilmington, North Carolina, 20841, United States

RECRUITING

MeSH Terms

Interventions

INNA-051

Central Study Contacts

ENA Respiratory

CONTACT

clinicaltrials@enarespiratory.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 30, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): February 9, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)