A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Concentration of Nipocalimab in Breast Milk
研究概览
简要总结
The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- •Study participant must have good venous accessibility in both arms
- •Study participant must be between 5 weeks and 24 months post-partum, inclusive, on Day -1
- •Study participant must agree, when nipple cream is needed during the assessment phase, to use only lanolin nipple cream
- •Study participant must have well established lactation and must be exclusively breast-feeding her infant (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study
排除标准
- •Study participant has history of breast implants, breast augmentation, or breast reduction surgery
- •Study participant currently has active or unresolved mastitis at screening or Day -1
- •Study participant currently has or had an active clinically significant infection within the last 6 weeks
- •Study participant has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol-specified assessments
- •Study participant has suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
研究组 & 干预措施
Healthy Lactating Participants
A single dose of nipocalimab will be administered to healthy lactating participants on Day 1. Breast milk samples will be collected and pharmacokinetic (PK) assessments will be done for the analysis of nipocalimab concentrations for up to Day 8.
干预措施: Breast Milk Sampling (Other)
Healthy Lactating Participants
A single dose of nipocalimab will be administered to healthy lactating participants on Day 1. Breast milk samples will be collected and pharmacokinetic (PK) assessments will be done for the analysis of nipocalimab concentrations for up to Day 8.
干预措施: Nipocalimab (Drug)
结局指标
主要结局
Concentration of Nipocalimab in Breast Milk
时间窗: Up to Day 8
The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported.
Area Under the Curve for Breast Milk Concentration
时间窗: Up to 168 hours postdose
Area under the curve for breast milk concentration vs time curve from time 0 to 168 hours post-dose will be reported.
次要结局
未报告次要终点