A Phase 1, Randomized, Placebo-controlled, Double Blind, Single, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX005 Monotherapy and ANX005 in Combination With IVIg in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, ascending, single-infusion, sequential group study. Single, ascending doses will be administered to approximately 64 subjects, with an option for 1 additional multi-dose cohort in approximately 8 subjects. The primary objective is to evaluate the safety of ANX005 administered as an intravenous infusion as a single agent and in combination with intravenous immunoglobulin (IVIg). The optional multi-dose cohort will evaluate either additional subjects at the maximum tolerated dose or ANX005 administered as 2 infusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females 18 years and older
- •Females must be postmenopausal, surgically sterilized, or willing and able to use 2 methods of contraception throughout the study and for 1 month after the final study visit
- •Willing and able to undergo vaccination if not vaccinated recently
排除标准
- •History of any autoimmune disease, meningitis, septicemia or pneumonia
- •History of hypercoagulable diseases, hyperviscosity, thrombosis, renal dysfunction or acute renal failure
- •Known genetic deficiencies of the complement cascade system
- •History of conditions whose symptoms and effects could alter protein catabolism or IgG utilization, e.g. protein-losing enteropathies or nephrotic syndrome
- •Body weight less than 50 kg or greater than 100 kg
- •Hypersensitivity or allergic reactions to any excipients in the ANX005 drug product
- •(Cohorts 4b and 5b) Known selective IgA deficiency or presence of antibodies to IgA at screening
- •(Cohorts 4b and 5b) Prior reaction or hypersensitivity to blood products, including IVIg or any of the excipients in IVIg.
研究组 & 干预措施
Placebo
Placebo intravenous infusion
干预措施: Placebos (Drug)
ANX005 Monotherapy
ANX005 intravenous infusion
干预措施: ANX005 (Drug)
ANX005 and IVIg Combination Therapy
ANX005 intravenous infusion in combination with intravenous immunoglobulin (IVIg)
干预措施: ANX005 (Drug)
ANX005 and IVIg Combination Therapy
ANX005 intravenous infusion in combination with intravenous immunoglobulin (IVIg)
干预措施: IVIg (Drug)
结局指标
主要结局
Number of subjects with treatment-related adverse events as assessed by CTCAE v4.03
时间窗: Day 43
Safety is assessed throughout the study. Day 43 is the last visit.
次要结局
- Peak plasma concentration(Day 43)
- Determine effective dose of ANX005(Day 43)
- Area under the plasma concentration versus time curve (AUC)(Day 43)
- Terminal half-life(Day 43)