A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CNTO 6785 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Number and type of Infusion (injection) site reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.
详细描述
This is a randomized (study drug will be assigned by chance), double-blind (neither the volunteer, physician, or study staff will know the identity of the assigned treatment), study to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785 administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous (under the skin) administration to healthy adult volunteers.This will be the first administration of CNTO 6785 to humans; therefore, no clinical experience is available. Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3 mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteer with no clinically significant abnormalities as determined by the investigator (study physician)
- •Have a body mass index (BMI) between 19-30 kg/m2
- •Be a non-smoker for at least 6 months prior to study participation
- •Women must be postmenopausal or surgically sterile
排除标准
- •Currently have or have a history of any clinically significant medical illness or medical disorders (includes malignancies or serious infections) that the investigator (study physician) considers should exclude the volunteer from the study
- •Major surgery or significant trauma within 12 weeks of screening
- •Any volunteer who plans to undergo elective surgery within 4 weeks prior to study agent administration and through the end of the study
- •Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day).
研究组 & 干预措施
001
CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg
干预措施: CNTO 6785 1 mg/kg IV (Drug)
002
CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg
干预措施: CNTO 6785 3 mg/kg IV (Drug)
003
CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg
干预措施: CNTO 6785 10 mg/kg IV (Drug)
004
Placebo IV A single 30-minute IV infusion of placebo
干预措施: Placebo IV (Drug)
005
CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
干预措施: CNTO 6785 SC (Drug)
006
Placebo SC A single SC dose of placebo administered in up to 3 SC injections
干预措施: Placebo SC (Drug)
结局指标
主要结局
Number and type of Infusion (injection) site reactions
时间窗: Up to Week 17
Vital signs measurements
时间窗: Up to Week 17
Clinical laboratory test results
时间窗: Up to Week 17
Number and type of adverse events reported
时间窗: Up to Week 17
Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry)
时间窗: Up to Week 17
次要结局
- Serum concentration of CNTO 6785(Up to Week 17)
- Serum antibodies to CNTO 6785(Up to Week 17)