ACTRN12616000862448终止1 期
Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Subcutaneous APL-9 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Medically healthy adults
- •Weigh more than 50 kg and less than 95 kg and have a BMI higher than 18.0 kg/m2 and lower than 32.0 kg/m2.
- •Have been vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenza within two years or willing to receive vaccinations.
排除标准
- •Mentally or legally incapacitated or has significant emotional problems or has a history of a significant medical or psychiatric condition or a history of hypersensitivity to compounds related to APL-9 or a history of chronic infections or a recent active infection or recent surgery.
- •Use of any prescription or non-prescription medications, herbal remedies, or vitamin supplements within the last 14 days
- •Blood donation or significant blood loss within previous 56 days or plasma donation within previous 7 days
- •Participation in another clinical trial within the previous 60 days or participation in any previous clinical trial with APL-9.
- •Female subjects who are pregnant or lactating.
研究者
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