NCT01579383已完成1 期
A Single Dose, Placebo-Controlled, Ascending Dose Study to Determine the Safety, Tolerability and Pharmacokinetics of ALD403, a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody Administered by Intravenous Infusion and Subcutaneous Injection
Alder Biopharmaceuticals, Inc.2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Safety and tolerability of ALD403: laboratory variables, ECG and adverse events
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD403, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females between the ages of 18 and 65 (inclusive).
- •Normal renal function as calculated by the Cockcroft- Gault equation at screening.
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100kg inclusive.
- •No clinically significant disease or abnormal laboratory values as determined by medical history, physical examination, electrocardiogram, and laboratory evaluations
排除标准
- •History of febrile illness within 5 days prior to the first dose
- •Any clinically significant laboratory findings
- •Any clinically significant physical exam abnormalities
- •Hospitalization for any reason within 30 days of the screening visit.
- •History of or positive human immunodeficiency virus (HIV) screen result
- •History of positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV) at screening.
- •History of malignancy within five years prior to screening.
- •History of leukemia, myeloproliferative disorder or lymphoproliferative disorder
- •History of rubber, latex allergy or allergy to medical adhesives
- •Positive urine, drug or alcohol screen result
- •Current smokers
- •Previous treatment or clinical trial with a monoclonal antibody.
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives
- •Inclusion Criteria Part B:
- •Healthy females between the ages of 18 and 65 (inclusive).
- •Male and female migraine patients with clinically diagnosed migraine not attributed to another cause with or without aura based on International Headache Society criteria.
- •Migraine patients must have a history of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study.
- •Normal renal function as defined by Cockcroft- Gault equation at screening.
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100kg inclusive.
- •No clinically significant disease or abnormal laboratory values as determined by medical history, physical examination, electrocardiogram, and laboratory evaluations conducted at the screening visit or at the time of admission
- •Exclusion Criteria Part B:
- •For migraine patients: patient is not able to refrain from use of their usual triptan therapy (if applicable) from 48 hours (Day -2) prior to dosing on Day 1 until the morning of discharge (Day 3).
- •Migraine patients who experience migraine with prolonged aura, familiar hemiplegic migraine, migrainous infarction or basilar migraine
- •For migraine patients: patient has more than 8 headache-days per month or has taken medication for acute headache on more than 8 days a month in the past 3 months
- •For migraine patients: patient was greater than 50 years old at the age of migraine onset
- •History of febrile illness within 5 days prior to the first dose
- •Any clinically significant laboratory findings
- •Any clinically significant physical exam abnormalities
- •Previous treatment or clinical trial with a monoclonal antibody.
- •Hospitalization for any reason within 30 days of the screening visit.
- •History of or positive human immunodeficiency virus (HIV) screen result
- •History of positive Hepatitis B surface antigen (HBsAg), and/or positive Hepatitis C antibody (HCV
- •History of malignancy within five years prior to screening.
- •History of leukemia, myeloproliferative disorder or lymphoproliferative disorder
- •Positive urine drug or alcohol screen result
- •Current smokers.
- •Known contraindication to sumatriptan
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives
结局指标
主要结局
Safety and tolerability of ALD403: laboratory variables, ECG and adverse events
时间窗: 12 weeks
* Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events
次要结局
- Evaluation of Pharmacokinetics of ALD403(12 weeks)
- Evaluation of pharmacodynamics of ALD403(12 weeks)
研究者
研究点 (2)
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