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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 5
- 主要终点
- Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
INNA-051
干预措施: INNA-051 (Drug)
结局指标
主要结局
Part A - Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 8 weeks
Part A - Percentage of Participants with TEAEs
时间窗: Up to 8 weeks
Part A - Number of participants with Serious Adverse Events (SAEs)
时间窗: Up to 8 weeks
Part A - Percentage of Participants with SAEs
时间窗: Up to 8 weeks
Part A - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
时间窗: Up to 4 weeks
Part A - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
时间窗: Up to 4 weeks
Part A - Change in White Blood Cell Count from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Platelet Count from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Hemoglobin from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Alanine Transaminase (ALT) from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Bilirubin (Total) from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Bilirubin (Direct) from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Alkaline Phosphatase (ALP) from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in Creatinine from Baseline
时间窗: Baseline up to 4 weeks
Part A - Change in High Sensitivity C-reactive Protein from Baseline
时间窗: Baseline up to 4 weeks
Part B - Number of Participants with TEAEs
时间窗: Up to 16 weeks
Part B - Percentage of Participants with TEAEs
时间窗: Up to 16 weeks
Part B - Number of Participants with SAEs
时间窗: Up to 16 weeks
Part B - Percentage of Participants with SAEs
时间窗: Up to 16 weeks
Part B - Number of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
时间窗: Up to 12 weeks
Part B - Percentage of Participants with Nasal Irritancy Questionnaire Symptoms (iTNSS Questionnaire)
时间窗: Up to 12 weeks
Part B - Change in White Blood Cell Count from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in Platelet Count from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in Hemoglobin from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in ALT from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in Bilirubin (Total) from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in Bilirubin (Direct) from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in ALP from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in Creatinine from Baseline
时间窗: Baseline up to 12 weeks
Part B - Change in High Sensitivity C-reactive Protein from Baseline
时间窗: Baseline up to 12 weeks
Part B - Number of Participants with Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR)-confirmed Symptomatic Viral Respiratory Infections
时间窗: 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
时间窗: 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.
次要结局
- 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)