NCT02623322已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, Administered as Monotherapy for the Treatment of Acute Uncomplicated Seasonal Influenza A Infection in Otherwise Healthy Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 79
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled single dose study in otherwise healthy adults with acute uncomplicated seasonal influenza A to assess the safety and tolerability, efficacy, and pharmacokinetics of MHAA4549A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy participants
- •Positive test for influenza A infection
- •No more than 72 hours elapsed between onset of influenza-like illness and start of study drug
- •Presence of at least one moderate or severe constitutional symptom such as headache, myalgia, fever, chills, fatigue, anorexia, or nausea PLUS one moderate or severe respiratory symptom such as cough, sore throat, or rhinorrhea
- •For women of childbearing potential: negative pregnancy test and agreement to use acceptable contraceptive methods for at least 120 days after study drug administration
- •For men: agreement to use acceptable contraceptive methods for at least 30 days after study drug administration
排除标准
- •Creatinine clearance less than or equal to (</=) 80 milliliters per minute (mL/min)
- •Any significant medical conditions or laboratory abnormalities
- •Clinical signs and symptoms consistent with otitis, bronchitis, sinusitis, or pneumonia or active bacterial infection
- •Use of antiviral therapy in the period from onset of influenza-like illness and prior to enrollment
- •Pregnancy at Screening or is currently pregnant or breastfeeding
- •Investigational therapy within 30 days or 5 half-lives prior to start of study drug, whichever is greater
- •Prior anti-influenza monoclonal antibody use
- •Receipt of a nasal influenza A vaccine within 14 days prior to Screening
- •Positive test for influenza B or influenza A+B within 2 weeks prior to study drug
- •History of significant tobacco use or drug/alcohol abuse
- •Chronic use of oral or inhaled corticosteroids within 30 days prior to Screening
- •Autoimmune disease, known immunodeficiency of any cause, or use of immunosuppressive medications
- •History of any chronic respiratory condition
- •Human immunodeficiency virus (HIV) with cluster of differentiation (CD) 4 count </= 200 cells per milliliter (cells/mL) in the past 12 months
- •Serious infection requiring oral or IV antibiotics within 14 days prior to Screening
研究组 & 干预措施
MHAA4549A 3600 milligrams (mg)
Experimental
Participants will receive single-dose MHAA4549A, 3600 mg, by intravenous (IV) administration.
干预措施: MHAA4549A (Drug)
MHAA4549A 8400 mg
Experimental
Participants will receive single-dose MHAA4549A, 8400 mg, by IV administration.
干预措施: MHAA4549A (Drug)
Placebo
Placebo Comparator
Participants will receive single-dose placebo by IV administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Baseline to Day 100
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.
次要结局
- Percentage of Participants Requiring Hospitalization for Influenza-Related Complications(Baseline to Day 100)
- Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections(Baseline to Day 100)
- Maximum Serum Concentration (Cmax) of MHAA4549A(Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours))
- Percentage of Participants With Complications of Influenza(Baseline to Day 100)
- Percentage of Participants With Influenza A Relapse/Reinfection(Baseline to Day 100)
- Area Under the Concentration-Time Curve (AUC) of MHAA4549A(Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours))
- Time to Alleviation of Symptoms of Influenza A Infection(Baseline to Day 14)
- Duration of Hospitalization for Influenza-Related Complications(Baseline to Day 100)
- Percentage of Participants With Influenza-Related Deaths(Baseline to Day 100)
研究者
研究点 (79)
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