A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a body weight in the range of 50 to 100 kilogram (kg), inclusive, and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m^2), inclusive, at screening and Day -1
- •Must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -1
- •Must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day -1
- •A woman must not be of childbearing potential
- •Must be a non-smoker or tobacco user or 3 months prior to screening
排除标准
- •Pregnant or breastfeeding while enrolled in this study or within 20 weeks after the dose of study treatment
- •History of or currently has any clinically significant medical illness or medical disorders the investigator considers significant, including, but not limited to immune deficiency state, liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- •Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- •Active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- •Has had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening and/or plan to receive a BCG vaccine within 12 months after the administration of study treatment
- •Has experienced a recent single dermatomal herpes zoster eruption within the past 6 months
- •Has a history of multi-dermatomal herpes zoster or central nervous system (CNS) zoster within the past 5 years
- •Has received prescription medications within 14 days prior to study treatment
研究组 & 干预措施
Daratumumab
Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20).
干预措施: Daratumumab (Drug)
Daratumumab
Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20).
干预措施: rHuPH20 (Drug)
Placebo
Participants will receive placebo as a single SC dose in each of first 7 cohorts.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo
时间窗: Up to Day 141
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo
时间窗: Up to Day 141
The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed.
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1 predose through Day 141)
- Time to the Maximum Observed Plasma Concentration (Tmax)(Day 1 predose through Day 141)
- Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies(Day 1 predose through Day 141)
- Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry(Day 1 predose through Day 141)
- Area Under the Plasma Concentration-time Curve From Time Zero to the Time Corresponding to the Last Quantifiable Serum Concentration (AUC [0-last])(Day 1 predose through Day 141)
- Area Under the Plasma Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUC[0- infinity])(Day 1 predose through Day 141)
- Number of Participants With Anti-daratumumab Antibodies(Day 1 predose through Day 141)