A Two-Part, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Subjects Employing the Intravenous Endotoxin-Induced Model of Acute Inflammation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- The TNF-α concentrations in plasma (Part 2)
研究概览
简要总结
The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398 using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.
详细描述
This is a 2-part, single center, double-blind study (neither physician nor participant knows the treatment that the participant receives). Part 1 is designed to evaluate the safety, tolerability, and pharmacokinetics (level of drug in the blood) of a dosing regimen of an investigational drug (JNJ-26528398) prior to its use in Part 2. In Part 1, participants will be assigned by chance to receive either 3 mg/day JNJ-26528398 (6 participants) or placebo (3 participants) for 7 consecutive days while staying in the clinic for 10 days. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. Part 2 is designed to evaluate the anti-inflammatory properties of JNJ-26528398 by measuring markers of inflammation in the blood after intravenous (IV) administration of a substance (endotoxin) which activates the immune system and temporarily causes flu-like symptoms. In Part 2, participants will be assigned by chance to receive up to 3 mg/day JNJ-26528398 (6 participants) or placebo (4 participants) for up to 7 consecutive days while staying in the clinic for 10 days. Endotoxin will be given on the last day of study drug administration. Participants will remain in bed for at least 6 hours after endotoxin administration and will be closely monitored by study personnel.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Nonsmoker
- •Be in good health on the basis of physical examination, medical history, and electrocardiogram (ECG)
- •Must have good exercise tolerance
- •Have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive
- •Have a history of consistent dental hygiene and dental care
- •Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
- •Must agree to not donate sperm during the study and for 3 months after study
排除标准
- •Is currently enrolled in an investigational study, has recently received an investigational drug (including investigational vaccines), or has donated blood within 3 months
- •Has had a vaccination within past 3 months
- •Has history of significant drug or alcohol abuse within past 2 years or has a positive drug screen
- •Blood donation within past 3 months
- •Part 2 only: Has received endotoxin within past 3 months, or has a known allergy or history of significant adverse reaction to endotoxin or its excipients lactose and polyethylene glycol 6000
研究组 & 干预措施
Treatment
干预措施: JNJ-26528398 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The TNF-α concentrations in plasma (Part 2)
时间窗: Days 7-8
次要结局
- Other markers of inflammation in blood (Part 2)(Days 7-8)
- Profile of Mood States (POMS) (Part 2)(Days 1 and 7)
- Incidence of adverse events amongst participants (Parts 1 and 2)(Days -1 to 10 and Day 24)
- Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2)(Days 1-10)
- Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2)(Days 1-10)