A Sequential, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-80202135 Following a Single Intravenous Administration in Healthy Chinese Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under the Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC [0-Infinity]) of Nipocalimab
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following single intravenous (IV) administration in healthy Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be assessed as not clinically significant by the investigator and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel 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
- •Serum immunoglobulin G (IgG) level must be greater than (>) the lower limit of normal at screening
- •Body mass index (BMI; weight [kilograms {kg}] per height^2 [meter square {m^2}]) between 18 and 27.9 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg and less than or equal to (<=) 110 kg at screening
- •A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at Week 0 prior to administration of study intervention
排除标准
- •Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- •Serum albumin below the lower limit of normal at screening
- •Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, acetaminophen, contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study
- •Had major surgery, (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 or within 8 weeks after the last dose of study intervention administration
- •Has an active, acute or a chronic infection (examples: bronchiectasis, chronic osteomyelitis, chronic pyelonephritis) or requires chronic treatment with anti-infectives (examples: antibiotics, antivirals)
研究组 & 干预措施
Cohort 1: Nipocalimab
Participants will receive a single intravenous (IV) dose of nipocalimab Dose 1 on Day 1.
干预措施: Nipocalimab (Drug)
Cohort 2: Nipocalimab
Participants will receive a single IV dose of nipocalimab Dose 2 on Day 1.
干预措施: Nipocalimab (Drug)
Cohort 3: Nipocalimab
Participants will receive a single IV dose of nipocalimab Dose 3 on Day 1.
干预措施: Nipocalimab (Drug)
结局指标
主要结局
Area Under the Analyte Concentration Versus Time Curve From Time Zero to Infinite Time (AUC [0-Infinity]) of Nipocalimab
时间窗: Up to Day 29
AUC (0-Infinity) is defined as area under the analyte concentration versus time curve from time zero to infinite time of nipocalimab.
Time of Last Measurable Serum Concentration (Tlast) of Nipocalimab
时间窗: Up To Day 29
Tlast is defined as time of last measurable serum concentration of nipocalimab.
Last Measurable Serum Concentration (Clast) of Nipocalimab
时间窗: Up to Day 29
Clast is defined as last measurable serum concentration of nipocalimab.
Total Systemic Clearance (CL) of Nipocalimab
时间窗: Up to Day 29
CL is defined as total systemic clearance of nipocalimab after intravenous (IV) administration.
Time to Reach the Maximum Observed Serum Concentration (Tmax) of Nipocalimab
时间窗: Up to Day 29
Tmax is defined as time to reach the maximum observed serum concentration of nipocalimab.
Apparent Elimination Half-life (T1/2) of Nipocalimab
时间窗: Up to Day 29
T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of nipocalimab.
Area Under the Serum Concentration Versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of Nipocalimab
时间窗: Up to Day 29
AUC(0-last) is defined as area under the serum concentration versus time curve from time 0 to time of the last measurable concentration of nipocalimab.
Maximum Observed Serum Concentration (Cmax) of Nipocalimab
时间窗: Up to Day 29
Cmax is defined as maximum observed serum concentration of nipocalimab.
Volume of Distribution (Vz) of Nipocalimab
时间窗: Up to Day 29
Vz is defined as volume of distribution based on terminal phase after IV administration of nipocalimab.
次要结局
- Percentage of Participants with Adverse Events (AEs)(Up to Day 57)
- Percentage of Participants with Serious Adverse Event (SAE)(Up to Day 57)
- Percentage of Participants with Adverse Event of Special Interests (AESIs)(Up to Day 57)
- Percentage of Participants with Abnormalities in Physical Examinations(Up to Day 57)
- Percentage of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG) Values(Up to Day 57)
- Percentage of Participants with Abnormalities in Vital Signs(Up to Day 57)
- Percentage of Participants with Abnormalities in Clinical Laboratory Values(Up to Day 57)
- Percentage of Participants with Anti-drug Antibodies to Nipocalimab(Day 1, Day 15, Day 29 and Day 57)
- Change from Baseline Over Time in Total Immunoglobulin-G (IgG) Serum Levels(Baseline up to Day 57)