NCT06720714已完成1 期
An Open-Label, Single-Dose Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Concentration of rozanolixizumab in breast milk over a 7-day Sampling Period
研究概览
简要总结
The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab
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
- •Study participant must be minimum 18 years at the time of signing the informed consent form (ICF)
- •Study participant is lactating and will be at least 6 weeks postpartum on Day 1 of the study
- •Study participant has voluntarily decided, prior to having knowledge of this study, to cease breast milk feeding (by any means) in relation to her current period of lactation. Study participant agrees to cease or suspend breast milk feeding by Day 1 of the study and to not resume breast milk feeding (by any means) or donate expressed breast milk for 8 weeks following administration of rozanolixizumab. Participants may decide to resume breast milk feeding 8 weeks after administration of rozanolixizumab, with the agreement that any breast milk collected (to maintain milk supply) during that 8-week period will be discarded
- •Study participant is female
- •A female participant is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- •A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the Sampling Period and for at least 1 week after the last dose of study treatment OR
- •Not a WOCBP (ie, premenopausal female with documented hysterectomy, documented bilateral salpingectomy, or documented bilateral oophorectomy)
排除标准
- •Study participant has history of breast implants, breast augmentation, or breast reduction surgery
- •Study participant has received live vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study
- •Study participant has received treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- •Study participant has had exposure to more than 3 new chemical entities within 12 months prior to dosing
- •Study participant has had an active clinically significant infection within the last 6 weeks
研究组 & 干预措施
Rozanolixizumab arm
Experimental
Study participants enrolled in this arm will receive a single dose of subcutaneous rozanolixizumab
干预措施: Rozanolixizumab (Drug)
结局指标
主要结局
Concentration of rozanolixizumab in breast milk over a 7-day Sampling Period
时间窗: From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.
The breast milk collection and sampling time points will be: within 30 minutes predose and at 0 to ≤3, ≤6, ≤9, ≤12, ≤24, ≤36, ≤48, ≤60, ≤72, ≤84, ≤96, ≤108, ≤120, ≤132 and ≤144 hours (Day 7) after the start of infusion.
次要结局
- Estimated daily infant dosage(From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.)
- Relative infant dose of rozanolixizumab from breast milk(From Day 1, 2, 3, 4, 5, 6 Visit up to Day 7 Visit.)
- Occurrence of TEAEs(From Day 1 Visit up to the Safety Follow-Up Visit (Week 9))
研究者
研究点 (4)
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