NCT03536325已完成1 期
A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration 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 guselkumab following single-dose intravenous (IV) infusion in Japanese healthy 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
- •Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
- •Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
- •Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study, if the inpatient site allows. However, if smoking is not allowed in the inpatient site, smokers will not be allowed to smoke while inpatient cannot use nicotine replacement products during the inpatient period, but may smoke at other times during the study, up to the maximum stated above
- •Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol per day for the duration of the study
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, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- •Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- •Any medical contraindications preventing study participation
研究组 & 干预措施
Cohort 1: Guselkumab Dose 1 or Placebo
Experimental
Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.
干预措施: Guselkumab Dose 1 (Drug)
Cohort 1: Guselkumab Dose 1 or Placebo
Experimental
Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.
干预措施: Placebo (Drug)
Cohort 2: Guselkumab Dose 2 or Placebo
Experimental
Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.
干预措施: Guselkumab Dose 2 (Drug)
Cohort 2: Guselkumab Dose 2 or Placebo
Experimental
Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.
干预措施: Placebo (Drug)
Cohort 3: Guselkumab Dose 3 or Placebo
Experimental
Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2.
干预措施: Guselkumab Dose 3 (Drug)
Cohort 3: Guselkumab Dose 3 or Placebo
Experimental
Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2.
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 approximately 20 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
- Number of Participants with Antibodies to Guselkumab(Day 1: predose; and Days 15, 29, 57, and 113)
- Maximum Observed Serum Concentration (Cmax)(Day 1: predose, end of infusion (EOI) and 8 hours (h) post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113)
- Total Systemic Clearance (CL)(Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113)
- Volume of Distribution (Vz)(Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113)
- Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time Corresponding to the Last Quantifiable Plasma Concentration (AUC[0-last])(Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113)
- Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])(Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113)
- Terminal half-life (t1/2)(Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113)
研究者
研究点 (1)
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