NCT04570267已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
研究概览
简要总结
Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive
- •Body weight of at least 45 kg to 100 kg, inclusive
- •Body mass index of 18.0 to 32.0 kg/m2, inclusive
排除标准
- •A clinically significant medical condition, disorder, or disease of any organ system.
- •Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening).
- •Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy.
- •Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count < 2.0 × 109/L).
- •History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.
研究组 & 干预措施
CSL324 (Low dose)
Experimental
One low dose of CSL324 administered subcutaneously on Day 1
干预措施: CSL324 (Biological)
CSL324 (High dose)
Experimental
One high dose of CSL324 administered subcutaneously on Day 1
干预措施: CSL324 (Biological)
Placebo
Placebo Comparator
One dose of placebo administered subcutaneously on Day 1
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL324 in serum
时间窗: From Day 1 to Day 56
Maximum concentration (Cmax) of CSL324 in serum
时间窗: From Day 1 to Day 56
Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL324 in serum
时间窗: From Day 1 to Day 56
次要结局
- Number of subjects with adverse events localized to the administration site by incidence, by severity, and by causality(Up to Day 7)
- Percentage of subjects with adverse events localized to the administration site by incidence, by severity, and by causality(Up to Day 7)
- Time to reach Cmax (Tmax) for CSL324 in serum(From Day 1 to Day 56)
- Apparent volume of distribution (Vz/F) for CSL324 in serum(From Day 1 to Day 56)
- Number of subjects with treatment-emergent adverse events (TEAEs) by incidence, by severity, and by causality(Up to Day 56)
- Terminal half-life (t1/2) for CSL324 in serum(From Day 1 to Day 56)
- Apparent clearance (CL/F) for CSL324 in serum(From Day 1 to Day 56)
- Number of subjects with or without anti-CSL324 antibodies(Up to Day 56)
- Percentage of subjects with or without anti-CSL324 antibodies(Up to Day 56)
- Percentage of subjects with TEAEs by incidence, by severity, and by causality(Up to Day 56)
研究者
研究点 (1)
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