ACTRN12616001438448已完成1 期
A phase 1, single-centre, randomised, double-blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of intravenous and subcutaneous CSL312 in healthy subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 48
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
- •- Male aged 18 to 45 years of age at the time of providing written informed consent.
- •- Judged as healthy by an investigator after completing a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •- Body mass index (BMI) of 18.0 to less than 30.0 kg/m^2.
排除标准
- •- Evidence of a clinically significant medical condition, disorder or disease including any of the following: hepatic (hepatitis, cirrhosis); biliary; renal; cardiac; bronchopulmonary; vascular; haematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic; psychiatric; immunodeficiency; cancer
- •- History of clinically significant arterial or venous thrombosis, bleeding disorder, or any abnormal coagulation test result at Screening (confirmed by repeat measurement)
- •- History of a severe allergic reaction with generalised urticaria; angioedema or anaphylaxis
- •- Abnormal clinical laboratory values and/or other study assessments, such as vital signs or ECG, deemed clinically significant by the investigator
- •- Positive serology test result for hepatitis B virus (HBV) surface antigen, human immunodeficiency virus (HIV) antibody, hepatitis A virus (HAV) antibody or hepatitis C virus (HCV) antibody at Screening
研究者
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