Viral Respiratory Illnesses, Viral Respiratory Infection
Conditions
Keywords
Respiratory virus, Viral respiratory infection, Viral respiratory illness, Prophylaxis, Intranasal, Viral respiratory disease
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.
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
DRUGINNA-051
powder nasal spray.
OTHERPlacebo
powder nasal spray.
Sponsors
ENA Respiratory Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Part B - Time to Symptom Resolution in Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections | Up to 12 weeks | Time to symptom resolution in participants with RT-qPCR-confirmed symptomatic viral respiratory infections will be measured using the RiiQ. |
| Part B - Duration of Infection for Participants with RT-qPCR-confirmed Symptomatic Viral Respiratory Infections | Up to 12 weeks | 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. |
| 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 | — |
Countries
United States
Contacts
CONTACTENA Respiratory
Outcome results
None listed