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Recruiting 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

Phase II Interventional Viral Respiratory Infection Viral Respiratory Illnesses

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INNA-051, Placebo.
Who it may be relevant to
Registry conditions: Viral Respiratory Infection, Viral Respiratory Illnesses. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Drug INNA-051
    powder nasal spray.
  • Other Placebo
    powder nasal spray.

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Part B - Number of Participants With RT-qPCR-confirmed Symptomatic Viral Respiratory Infections by Pathogen [Time frame: 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 [Time frame: Up to 12 weeks]
  • Part B - Time to Symptom Resolution in Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections [Time frame: Up to 12 weeks]
  • Part B - Duration of Infection for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections [Time frame: 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]) [Time frame: Up to 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 5 centers
  • Center for Vaccine Development and Global Health (CVD) — Baltimore
  • Naval Medical Research Command (NMRC) — Bethesda
  • Accellacare of Raleigh — Raleigh
  • Accellacare of Piedmont HealthCare — Statesville
  • Accellacare - Wilmington — Wilmington

Identifiers

NCT: NCT07222670 · INNA-051-POC-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗