NCT05407818已完成1 期
A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum Concentrations of JNJ-63733657
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Healthy for their age group on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Body mass index (BMI) between 18 and 35 kilograms per meter square (kg/m^2) (inclusive), and body weight greater than 50 kilograms (kg) but less than 80 kg (in order not to exceed the total dose of 5 grams [g] JNJ-63733657) at screening
- •Blood pressure (after the participant is supine for 5 minutes) between 90 and 150 millimeters of mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted. The participant will be considered eligible if any one of the blood pressure assessments within the range of 90-150 systolic and less than 90 diastolic
- •Willing and able to adhere to the prohibitions and restrictions specified in the protocol
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
- •Known allergies, hypersensitivity, or suspected intolerance to any biologic medication or known allergies, or clinically significant reactions to human proteins, monoclonal antibodies or antibody fragments, JNJ-63733657 or its excipients
- •Taken any disallowed therapies, concomitant therapy before the planned administration of study intervention. The use of medication that is considered not to have any impact on the study results may be allowed after agreement between the investigator and the sponsor's medical monitor
- •Received an investigational drug (including vaccines) or used an experimental medical device within 3 months or within a period less than 5 times the drug's half-life, if known, whichever is longer, before the administration of study intervention
- •Preplanned surgery or procedures that would interfere with the conduct of the study
研究组 & 干预措施
JNJ-63733657
Experimental
Participants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1.
干预措施: JNJ-63733657 (Drug)
结局指标
主要结局
Serum Concentrations of JNJ-63733657
时间窗: Up to Week 13
Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.
次要结局
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 17)
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity(Up to Week 13)
- Percentage of Participants with Discontinuations due to AEs(Up to Week 17)
- Percentage of Participants with Anti-drug Antibodies to JNJ-63733657(Up to Week 13)
- Percentage of Participants with Clinically Significant Changes in Vital Signs(Up to Week 17)
- Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)(Up to Week 17)
- Percentage of Participants with Clinically Significant Changes in Clinical Safety Laboratory Parameters(Up to Week 17)
研究者
研究点 (1)
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