NCT01093040已完成1 期
A Phase I, Single-Center, Single-blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CAT-354 Following Subcutaneous Administration in Healthy Male and Female Japanese Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.
详细描述
The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 20 through 55 years at the time of screening
- •Signed and dated written informed consent is obtained prior to any study related procedure taking place
- •No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- •A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- •Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
- •A negative screen for drugs of abuse and alcohol
- •The following reproductive criteria apply:
- •Females(of child bearing potential) must have a negative pregnancy test prior to the dose of investigational product and, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has a sterile male partner, or at least 2 years postmenopausal, or practices abstinence; must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted hormonal contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide, or use of a condom with spermicide by the sexual partner) for 21 days prior to randomization, and must agree to continue using such precautions until 3 months after dosing with the investigational product; cessation of birth control after this point should be discussed with a responsible physician. A negative pregnancy test is required both at screening and prior to dosing.
- •Males, unless surgically sterile, must use two effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from 21 days prior to randomization until 3 months after dosing with the investigational product.
- •Japanese subjects. To be considered as 'Japanese', both of the subject's parents, and both sets of grandparents, must be Japanese. The subject must have been born in Japan, have a valid Japanese passport, and must not have lived outside Japan for more than 5 years.
- •Body mass index (BMI) between 18 and 27 kg/m 2 , inclusive
- •Able to comply with the requirements of the protocol
排除标准
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- •Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354 or to any component of the investigational product formulation
- •History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection
- •Any acute illness in the 14 days before Day 1 (Visit 2)
- •Use of any medication (prescription or OTC) excluding hormonal contraception within 14 days (or 5-half lives, whichever is longer) of Day 1 dosing
- •Involvement in another study of investigational medicinal product; within 2 months of the start of this study (Day 1) for small molecules, within 3 months of the start of this study for antibodies, or 5 half lives of the previously administered investigational product, whichever is the longer
- •Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
- •Subjects with immunodeficiency disorders
- •Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •Any active concomitant disease including psychological disorders
- •Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first-degree relative of the aforementioned.
- •Any factor which, in the opinion of the Investigator, would be associated with poor adherence to the protocol
- •Female subjects: lactation
研究组 & 干预措施
Cohort 1
Experimental
CAT-354 will be administered by SC injection
干预措施: CAT-354 (Drug)
Cohort 2
Experimental
CAT-354 will be administered by SC injection
干预措施: CAT-354 (Drug)
Cohort 3
Experimental
CAT-354 will be administered by SC injection
干预措施: CAT 354 (Drug)
结局指标
主要结局
Safety
时间窗: Study Day 71
The safety and tolerability of a single dose SC injection of CAT-354 in healthy male and/or female Japanese subjects will be assessed through the incidence of adverse events (AEs), and the assessment of vital signs, physical examinations, laboratory parameters, and electrocardiograms.
次要结局
- Immunogenicity(Study Day 71)
研究者
研究点 (1)
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