EUCTR2011-005929-49-GB进行中（未招募）不适用
A Phase 2a, Randomized, Double Blind, Placebo Controlled Study to Investigate the Effects of VX 787 Administered to Adult Volunteers Experimentally Inoculated with Live Influenza Virus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Healthy male and female subjects
- •- Negative human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) antibody screen
- •- Negative Class A drugs and alcohol screen before dosing
- •- Serosuitable for the challenge strain of influenza A
- •- Have not been vaccinated for influenza virus since 2006 or had a known influenza-like illness in the current season (as determined in the medical history), defined as in the last 12 months before screening
- •- Willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, contraceptive guidelines, and other study procedures, including willingness to enter and remain in quarantine (in isolation for approximately 10 days) until free of influenza infection, as determined by rapid antigen test or clinical evaluation
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects who are male and their female partner (if of childbearing potential) does not agree to use medically approved methods of contraception
- •- Subjects who are pregnant or nursing, or who are male and have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period
- •- Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
- •- Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry
- •- Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge)
- •- Subjects with a history of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology; any history during adulthood of asthma of any etiology, chronic obstructive pulmonary disease, or any use of a bronchodilator or other asthma medication during adulthood
- •-Regular daily smokers during the 6 months before study entry or those who have a significant history of any tobacco use at any time
- •- History of heart failure or any other severe cardiac abnormality including clinically significant arrhythmia
- •- Use of any prescription drugs, herbal supplements, within 4 weeks before drug IMP administration, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks before viral challenge.
- •- Receipt of any investigational drug within 3 months, or prior participation in a clinical trial of any influenza vaccine, medication or experimental respiratory viral challenge delivered directly to the respiratory tract within 1 year before viral inoculation
- •- Previous exposure to the IMP or similar substance(s).
研究者
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