A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating CNTO 3157 in Healthy Normal and Asthmatic Subjects Inoculated With Human Rhinovirus Type 16
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Understanding of the study and a signed informed consent form before any study-related procedures
- Willing and able to adhere to the restrictions specified in the protocol
- Results of the following laboratory tests within the following limits: serum alanine aminotransferase (ALT) levels ≤2 x ULN; serum aspartate aminotransferase (AST) levels ≤2 x ULN
- Part 1 (healthy participants):
- a). Body weight in the range of 40 to 125 kg, inclusive. Have a body mass index (BMI) of 19 to 32 kg/m2, inclusive
- b). Healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, coagulation and urinalysis, measurement of vital signs, and 12-lead electrocardiogram (ECG) performed at Screening Visit 2
- Part 2:
- a). (BMI) of 19 to 40 kg/m2, inclusive; have a physician-documented diagnosis of asthma for at least 6 months prior to Screening Visit 2; have stable asthma based on physician assessment at Screening Visit 2
- b). Have an Asthma Control Questionnaire (ACQ) symptom score less than (<)2.5 at Screening Visit 2
- c). Have a prebronchodilator forced expiratory volume in the first second (FEV1) greater than or equal to (>=) 65 percent of predicted normal value at Screening Visit 2
Exclusion Criteria:
- Part 1 (healthy participants): Has any condition that in the opinion of the investigators, would constitute a risk or a contraindication for participating in the study, prevent the participant from meeting or performing study requirements, or could interfere with the study objectives, conduct, or evaluation
- At Screening Visit 1 and throughout the study, works with (or lives with a family member who cares for) the elderly, (eg, nursing home), or lives with someone who may be at risk from transmission of the human rhinovirus type 16 (HRV-16) challenge agent, including, but not limited to, individuals with chronic lung disease (including asthma), a premature infant, or an immunocompromised individual
- Has had any acute illness, including a common cold, within 4 weeks prior to Screening Visit 1, or has had a major illness or hospitalization within 6 months prior to Screening Visit 1
- Has active allergic rhinitis or perennial allergy symptoms (eg, due to ragweed) at Screening Visit 2 or expects to have active allergic rhinitis or perennial allergy symptoms during the study
- Has a current infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized and/or received antimicrobials for a serious infection during the 6 months prior to Screening Visit 1
- Part 2 (asthmatic patients): Has a history of any other chronic lung disease, including chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease, liver or renal insufficiency; significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, or other body system disorders that are clinically significant in the opinion of the investigator
- Has ever had an episode of life-threatening asthma defined as respiratory arrest or requiring intubation for asthma
- Has been hospitalized (for greater than 24 hours) due to asthma in the 5 years prior to Screening Visit 1
- Has experienced an asthma exacerbation in the 12 weeks prior to Screening Visit 1 requiring management with systemic steroids
- Is receiving a high-dose inhaled corticosteroid (ICS) (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (≤500 µg/day fluticasone or equivalent) with or without permitted controller medications, eg, long-acting Beta2 agonists (LABA), leukotriene receptor antagonists (LTRA), is allowed
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Part 1: Healthy participants (CNTO 3157 + HRV-16)
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CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).
Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
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安慰剂比较:Part 1: Healthy participants (placebo + HRV-16)
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Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.
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实验性的:Part 2: Asthmatic patients (CNTO 3157 + HRV-16)
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Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22).
The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
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安慰剂比较:Part 2: Asthmatic patients (placebo + HRV-16)
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Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22).
The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The maximum percent decrease relative to baseline in the prebronchodilator forced expiratory volume in 1 second (FEV1) measurements (Part 2)
大体时间:Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
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Up to 10 days after inoculation with human rhinovirus type 16 (HRV-16)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Area under the serum concentration versus time curve (AUC) of change from baseline in Cold Symptom Assessment Score
大体时间:Up to 10 days after inoculation with HRV-16
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Cold symptoms is rated using a 5 point scale (0=none and 4=very severe).
Scores can range from 0-32, with higher scores indicating more symptoms.
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in Cold and Chest Symptom Scale
大体时间:Up to 10 days after inoculation with HRV-16
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Cold and chest symptoms are rated using a 5 point scale: 0 using a 5 point scale (0=none and 4=very severe).
Scores can range from 0-60, with higher scores indicating more symptoms.
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in log-transformed fractional concentration of exhaled nitric oxide (FENO)
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the percent change from baseline in clinic assessed prebronchodilator FEV1
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in morning (AM) peak expiratory flow rate (PEFR)
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator percent predicted FEV1
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator forced vital capacity (FVC)
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator forced expiratory flow at 25 to 75% of vital capacity (FEV25-75)
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of the change from baseline in prebronchodilator FEV1/FVC
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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AUC of change from baseline in average total asthma symptom diary score
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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Change from baseline in Asthma Control Questionnaire (ACQ)
大体时间:Up to 10 days after inoculation with HRV-16
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ACQ is an instrument designed to evaluate asthma control.
Seven items are scored on a 7-point scale (0=good control, 6=poor control) with the mean score as an overall summary score.
Questions 1-6 are completed by the patient; the last item is entered by site personnel and corresponds to the patient's percent predicted FEV1 categorized according to the 7-point scale.
Higher scores reflect poorer control.
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Up to 10 days after inoculation with HRV-16
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Change from baseline in Cold Symptom Assessment Score
大体时间:Up to 11 weeks
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Clinical symptoms to HRV-16 will be assessed by using the Cold Symptom Assessment Score, wherein participants will report the presence and severity of their cold symptoms in the context of the previous 24 hours via an interactive interview with the study staff.
The symptoms consist of nasal congestion (stuffy nose), rhinorrhea (runny nose), sore throat, sneezing, cough, headache, malaise (feeling run down, tired) and chilliness.
Severity is rated using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe).
Scores can range from 0-32, with higher scores indicating more symptoms.
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Up to 11 weeks
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Change from baseline in Cold and Chest Symptom Scale
大体时间:Up to 11 weeks
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The Cold and Chest Symptom Scale contains 15 items composing 2 domains, a total cold score and a total chest score. Together, these 2 domains comprise the chest symptom assessment score. Total Cold Score domain: sneezing, runny nose, blocked or stuff nose, sore throat or hoarse voice, headache or face pain, generally unwell, chills, fever or shivery and cough and Total Chest Score domain: cough on waking, wheeze on waking, daytime cough, daytime wheeze, daytime chest tightness, daytime breathlessness and nocturnal cough, wheeze and breathlessness. Severity is rated using a 5 point scale: 0 using a 5 point scale (0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe). Scores can range from 0-60, with higher scores indicating more symptoms. |
Up to 11 weeks
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Change from baseline in log-transformed FENO over time
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FEV1
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in percent-predicted prebronchodilator and postbronchodilator FEV1
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FVC
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FEV25-75
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline over time in prebronchodilator and postbronchodilator FEV1/FVC
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline in morning/evening PEFR over time
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline in Total Nasal and Ocular Symptom Score (TNOSS)
大体时间:Up to Day 22
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Nose and eye symptoms are rated by the patient using a 5-point categorical response scale from 0 to 4, where 0 indicates absent/no symptom, and 4 indicates extremely severe symptoms, with a 24-hour recall period.
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Up to Day 22
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Change from baseline in average total asthma symptom diary score
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline in average number of nocturnal awakenings
大体时间:Up to 11 weeks
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Up to 11 weeks
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Change from baseline in average rescue medication use over time
大体时间:Up to 11 weeks
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Up to 11 weeks
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Number of symptom-free days
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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The maximum decrease from baseline in the prebronchodilator FEV1 measurements
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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Time to the maximum decrease relative to baseline in prebronchodilator FEV1
大体时间:Up to 10 days after inoculation with HRV-16
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Up to 10 days after inoculation with HRV-16
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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