A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Number of Participants with Electrocardiogram (ECG) Abnormalities
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administration in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 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
- •Healthy on the basis of clinical laboratory tests performed at screening
- •Continuous non-smoker
- •A woman of childbearing potential must have a negative pregnancy test
- •It is recommended that participants are up to date on all age appropriate vaccinations prior to screening as per routine local medical guidelines
排除标准
- •Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Currently has a malignancy or has a history of malignancy within 3 years before screening
- •Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- •Has received a live vaccine within 3 months prior to screening or has a known need to receive a live vaccine during the study, or within at least 3 months after the last administration of study intervention in this study
- •Shows evidence of an active or chronic hepatitis B infection
研究组 & 干预措施
Part 1: Single Dose Cohorts
Participants will receive subcutaneous (SC) injection or intravenous (IV) infusion of nipocalimab or placebo in single ascending doses on Day 1 in Cohorts 1-6 and SC administration in optional Cohorts 7-8.
干预措施: Nipocalimab (Drug)
Part 1: Single Dose Cohorts
Participants will receive subcutaneous (SC) injection or intravenous (IV) infusion of nipocalimab or placebo in single ascending doses on Day 1 in Cohorts 1-6 and SC administration in optional Cohorts 7-8.
干预措施: Placebo (Other)
Part 2: Multiple Dose Cohorts
Participants will receive up to 4 weekly SC injections of nipocalimab or placebo on Days 1, 8, 15, and 22 in Cohort 1 or 4 biweekly SC injections on Days 1, 15, 29, and 43 in optional Cohort 2.
干预措施: Nipocalimab (Drug)
Part 2: Multiple Dose Cohorts
Participants will receive up to 4 weekly SC injections of nipocalimab or placebo on Days 1, 8, 15, and 22 in Cohort 1 or 4 biweekly SC injections on Days 1, 15, 29, and 43 in optional Cohort 2.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants with Electrocardiogram (ECG) Abnormalities
时间窗: Up to Day 85
Number of participants with ECG abnormalities will be reported.
Percentage of Participants with Adverse Events (AEs)
时间窗: Up to Day 85
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Percentage of Participants with Reasonably Related AEs
时间窗: Up to Day 85
Percentage of participants with reasonably related AEs will be reported. Reasonably related AE is an AE that has a casual relationship with the pharmaceutical/biological agent under study.
Percentage of Participants with Serious Adverse Event (SAE)
时间窗: Up to Day 85
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
时间窗: Up to Day 85
Percentage of participants with AEs leading to discontinuation of study intervention will be reported. The participants were discontinued from the study by the investigator if the safety reasons or tolerability reasons such as an AE, it is in the best interest of the participant to discontinue study intervention.
Number of Participants with Vital Signs Abnormalities
时间窗: Up to Day 85
Number of participants with vital signs abnormalities including body temperature, pulse/heart rate, respiratory rate, blood pressure will be reported.
Number of Participants with Subcutaneous (SC) Injection-site Reactions
时间窗: Up to Day 85
Number of participants with SC injection-site reactions will be reported. An injection-site reaction is any AE at a SC study intervention injection-site.
Percentage of Participants with Adverse Events of Special Interest (AESIs)
时间窗: Up to Day 85
Percentage of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered as AESI; a) severe or medically significant or immediately life-threatening infections requiring intravenous (IV) anti-infective or operative/invasive intervention or requiring hospitalization or prolongation of existing hospitalization; b) hypoalbuminemia with albumin less than (\<) 20 grams per liter (g/L). Treatment-emergent AEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Clinical Laboratory Abnormalities
时间窗: Up to Day 85
Number of participants with clinical laboratory abnormalities related to hematology, serum chemistry and urinalysis will be reported.
次要结局
- Serum Concentration of Nipocalimab(Up to Day 85)
- Change from Baseline in Immunoglobulin (Ig) Levels Over Time(Baseline to Day 85)
- Number of Participants with Antibodies to Nipocalimab(Up to Day 85)