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

Genentech Inc.0 个研究点目标入组 141 人开始时间: 2016年6月6日最近更新: 2018年1月8日

研究概览

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•Otherwise healthy adults
•Positive test for influenza A infection
•No more than 3 days 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 41

•Creatinine clearance less than or equal to (•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 enrolment
•Patients who are currently pregnant, breastfeeding, or have a positive pregnancy test at screening, or are intending to become pregnant during the study
•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 •Serious infection requiring oral or intravenous (IV) antibiotics within 14 days prior to Screening

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