NCT03689153已完成1 期
A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy 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
- 24
- 试验地点
- 1
- 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 purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI; weight [kilogram {kg}]/height [meter square {m^2}]) between 18 and 35 kilogram per meter square (kg/m^2), inclusive, and a body weight greater than 50 kg but less than 110 kg at screening and Day -
- •For participants to be enrolled in the highest dose cohort (Cohort 3), additional weight limitations will apply in order not to exceed the total dose of 5 gram (g) JNJ-63733657; the participant weight in the highest dose cohort will be limited
- •Women must not be of childbearing potential
排除标准
- •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
- •Clinically significant abnormal values for hematology, clinical chemistry, coagulation, or urinalysis at screening and Day -1 in the opinion of the investigator
- •Clinically significant abnormal physical or neurologic examination (including fundoscopy), vital signs, or 12-lead electrocardiogram (ECG) at screening and Day -1 in the opinion of the investigator
- •Positive result on hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody (antiHCV) positive, or any other clinically active liver disease at screening (per screening evaluations)
- •History of human immunodeficiency virus (HIV) antibody positive, tests positive for HIV or tests positive for syphilis at screening
- •Mini-Mental State Examination (MMSE) score less than or equal to (<=) 27 at screening
研究组 & 干预措施
Cohort 1: JNJ-63733657 or Placebo
Experimental
Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.
干预措施: JNJ-63733657 (Drug)
Cohort 1: JNJ-63733657 or Placebo
Experimental
Participants will receive a single intravenous (IV) low dose of JNJ-63733657 or matching placebo.
干预措施: Placebo (Drug)
Cohort 2: JNJ-63733657 or Placebo
Experimental
Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo.
干预措施: JNJ-63733657 (Drug)
Cohort 2: JNJ-63733657 or Placebo
Experimental
Participants will receive a single IV middle dose of JNJ-63733657 or matching placebo.
干预措施: Placebo (Drug)
Cohort 3: JNJ-63733657 or Placebo
Experimental
Participants will receive a single IV high dose of JNJ-63733657 or matching placebo.
干预措施: JNJ-63733657 (Drug)
Cohort 3: JNJ-63733657 or Placebo
Experimental
Participants will receive a single IV high dose of JNJ-63733657 or matching placebo.
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: Approximately 23 weeks
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Area Under the Serum Concentration-Time Curve from Time Zero to the Time Corresponding to Last Quantifiable Serum Concentration (AUC [0-last])(Up to Day 106)
- Area Under the Serum Concentration-Time Curve from Time Zero to Infinite Time (AUC [0-infinity])(Up to Day 106)
- Elimination Rate Constant (Lambda[z]) of JNJ-63733657 in Serum(Up to Day 106)
- Apparent Elimination Half-Life (t1/2) of JNJ-63733657 in Serum(Up to Day 106)
- JNJ-63733657 Concentration in Cerebrospinal Fluid (CSF)(Up to Day 92)
- Number of Participants with Anti-JNJ-63733657 Antibodies(Up to Day 106)
- Percentage Change from Baseline in Total, Free, and Bound tau Biomarker Fragments in CSF(Up to Day 92)
- Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-63733657(Up to Day 106)
- Maximum Observed Serum Concentration (Cmax) of JNJ-63733657(Up to Day 106)
- Area Under the Serum Concentration-Time Curve from Time Zero to Time to 56 Days (AUC [0-56days])(0 hours (Day 1) up to 56 days)
- Total Systemic Clearance (CL) of JNJ-63733657 in Serum(Up to Day 106)
- Volume of Distribution (Vz) of JNJ-63733657 in Serum(Up to Day 106)
研究者
研究点 (1)
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