NCT01980966已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study in Healthy Volunteers to Evaluate the Efficacy and Safety of MHAA4549A in an Influenza Challenge Model
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
- 101
- 试验地点
- 1
- 主要终点
- Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 health with no history of major medical conditions from medical history, physical examination and routine laboratory tests
- •Male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until Day 120 follow-up visit
- •Sero-suitable for challenge virus
排除标准
- •Women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study
- •Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the CI
- •Abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry
- •History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment.
- •History suggestive of respiratory infection within 14 days prior to admission to the unit
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
MHAA4549A
Experimental
干预措施: MHAA549A (Drug)
Tamiflu
Active Comparator
干预措施: oseltamivir [Tamiflu] (Drug)
结局指标
主要结局
Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)
时间窗: 8 days
次要结局
- Safety: Incidence of adverse events(120 days)
- Safety: Change in lung function(from pre-challenge to Day 29)
- Safety: Incidence of anti-therapeutic antibodies (ATAs)(120 days)
- Pharmacokinetics: Area under the concentration-time curve(8 days)
- AUC of nasopharyngeal viral load, as measured by cell culture(8 days)
- Peak viral load (qPCR and cell culture)(8 days)
- Duration of viral shedding(8 days)
- Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom)(8 days)
- Peak/AUC of composite symptoms(8 days)
研究者
研究点 (1)
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