NCT01475305终止1 期
A Phase 1 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of MEDI-557 in Healthy Adults Intranasally Challenged With Respiratory Syncytial Virus (RSV)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture
研究概览
简要总结
The primary objective is to evaluate the suitability of the challenge model in measuring the efficacy of MEDI-557 compared to placebo in healthy adult participants for the reduction in the incidence of RSV through 12 days post-RSV challenge with the RSV Memphis-37 strain.
详细描述
This is designed to be a double-blind, placebo-controlled, randomized study. Approximately 30 participants will be randomized, dosed and followed. Participants will be randomly assigned to receive a single intravenous (IV) dose of MEDI-557 or placebo. Participants will be inoculated with RSV-A. Participants will be followed for efficacy for 12 days post-RSV challenge. Safety follow-up will be approximately 12 months from randomization.
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
- Triple (Participant, Care Provider, 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
- •Healthy as determined by medical history and physical examination.
- •Age 19 through 38 years at the time of screening.
- •Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- •Weight less than or equal to (<=) 10 kilogram (kg) with body mass index (BMI) less than (<) 32 kilogram per meter square (kg/m^2).
- •Normotensive (systolic blood pressure [BP] <150 millimeters of mercury (mmHg) and diastolic BP < 90 mmHg).
- •Females of childbearing age using contraception.
- •Males who are sexually active with a female partner of childbearing potential, using contraception.
- •Sero-suitable (that is, low serum RSV neutralizing antibody titre) for RSV infection.
排除标准
- •Current medical conditions as follows:
- •Clinical evidence of chronic pulmonary disease or any use of a bronchodilator or other asthma medication.
- •Current smoker unwilling/unable to desist for the quarantine phase of the study.
- •History or clinical evidence of recurrent lower respiratory tract infection.
- •Evidence of infection with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) by serology.
- •Medical history as follows:
- •History of immunodeficiency.
- •History of chronic sinusitis.
- •History of frequent epistaxis.
- •History of or current diagnosis of diabetes.
- •Prior/concomitant therapy including
- •Receipt of any systemic chemotherapeutic agent at any time;
- •Receipt of systemic glucocorticoids within 1 month, or any other immunosuppressive drug within 6 months prior to challenge.
- •Receipt of any investigational drug within 6 months prior to dose or concurrent enrolment in another clinical study.
- •Prior participation in a clinical trial of any experimental RSV viral challenge delivered directly to the respiratory tract at any time, or any other respiratory virus challenge within 1 year prior to dose.
- •Nursing mother.
- •Alcohol or drug addiction/abuse within the past 2 years.
- •A positive urine Class A drug or alcohol screen unless there is a medical reason.
- •History of seasonal hay fever or seasonal allergies.
- •Employees of the clinical study site or sponsor, any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- •Health care workers anticipated to have patient contact within 2 weeks after viral challenge.
- •Participants who, for an additional 2 weeks after discharge from the isolation facility, are likely to have contact with a household member or close contact with someone who is: (a) less than 3 years of age; (b) any person with any known immunodeficiency; (c) any person receiving immunosuppressant medications; (d) any person undergoing or soon to undergo cancer chemotherapy within 28 days of challenge; (e) any person who has diagnosed emphysema or COPD, is elderly residing in a nursing home, or with severe lung disease or medical condition; or (f) any person who has received a transplant (bone marrow or solid organ).
- •As a result of the medical interview, physical examination, or screening investigations, the investigator(s) considers the participant unfit for the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
干预措施: Placebo (Drug)
MEDI-557
Experimental
Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
干预措施: MEDI-557 (Drug)
结局指标
主要结局
Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture
时间窗: From Day 4 to Day 15
RSV infection is defined as positive plaque assay culture sample for greater than or equal to (\>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter \[pfu/mL\] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (\>) 0 pfu/mL.
次要结局
- Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method(From Day 4 to Day 15)
- Mean Viral Load AUC0-t by Plaque Assay Culture(From Day 5 through Day 31)
- Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)(From Day 5 through Day 31)
- Mean Nasal RSV Peak as Measured by Plaque Assay Culture(From Day 5 through Day 31)
- Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)(From Day 5 through Day 31)
- Duration of Respiratory Syncytial Virus (RSV) Viral Shedding(From Day 5 through Day 31)
- Mean Serum MEDI-557 Concentration Through Day 360(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Maximum Serum Concentration (Cmax) of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Serum Half Life (t1/2) of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Volume of Distribution at Steady-State (Vss) of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Mean Clearance of MEDI-557(Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360)
- Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points(Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31)
- Maximum Nasal Wash Concentration (Cmax) of MEDI-557(Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31)
- Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557(Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31)
- Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557(Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31)
- Percentage of Participants With Positive Anti-MEDI-557 Antibodies(Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(From Day 1 (immediately following administration of study drug) to Day 360)
- Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)(From Day 1 through Day 31)
- Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)(From Day 1 through Day 91)
- Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values(Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31)
研究者
研究点 (1)
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