A Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
研究概览
简要总结
The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of the study including the procedures required and are willing to participate in the study
- •Participant must be willing and able to adhere to the study visit schedule, prohibitions and restrictions specified in the protocol, and other protocol requirements
- •Participant must have a body weight in the range of 60 to 90 kilogram (kg), inclusive, and a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2)
- •Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Participant must be a non-smoker for at least 3 months prior to study enrollment
排除标准
- •Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- •Participant has or has had a serious infection (example, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 2 months prior to screening
- •Participant has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, and aspergillosis) prior to screening
- •Participant has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis prior to screening
- •If participant has had a chest radiograph within 3 months before study drug administration radiograph that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB)
研究组 & 干预措施
Cohort 3: JNJ-64304500 400 mg or placebo
Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 1: JNJ-64304500 50 milligram (mg) or placebo
Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.
干预措施: JNJ-64304500 (Drug)
Cohort 1: JNJ-64304500 50 milligram (mg) or placebo
Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 2: JNJ-64304500 150 mg or placebo
Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.
干预措施: JNJ-64304500 (Drug)
Cohort 2: JNJ-64304500 150 mg or placebo
Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.
干预措施: Placebo (Drug)
Cohort 3: JNJ-64304500 400 mg or placebo
Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.
干预措施: JNJ-64304500 (Drug)
Cohort 4: JNJ-64304500 150 mg or placebo
Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.
干预措施: JNJ-64304500 (Drug)
Cohort 4: JNJ-64304500 150 mg or placebo
Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Up to End of Study (Day 112)
次要结局
- Maximum Observed Serum Concentration (Cmax)(Up to End of Study (Day 112))
- Time to Reach Maximum Observed Serum Concentration (Tmax)(Up to End of Study (Day 112))
- Elimination Half-Life (t1/2)(Up to End of Study (Day 112))
- Apparent Volume of Distribution (Vd/F)(Up to End of Study (Day 112))
- Apparent Total Clearance (CL/F)(Up to End of Study (Day 112))
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])(Up to End of Study (Day 112))
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])(Up to End of Study (Day 112))
- Antibodies to JNJ-64304500(Up to End of Study (Day 112))
- Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500(Up to End of Study (Day 112))