ACTRN12620001156976已完成1 期
An Open-label, Single-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Inclacumab Following Intravenous Infusion in Healthy Participants
inear Clinical Research Ltd0 个研究点目标入组 15 人开始时间: 2020年11月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female participants between 18 and 65 years of age, inclusive.
- •2. Participants in good health as determined by the Investigator’s review of medical history,
- •physical examination, vital sign measurements, 12-lead ECG, and clinical laboratory
- •3. Body weight equal to or greater than 50 kg (male) or equal to or greater than 45 kg (female), and equal to or less than 110 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- •4. Ability to comply with all the requirements of the study.
排除标准
- •1.. Use of prescription medications or herbal remedies within 14 days of the Day -1 (with the
- •exceptions of hormonal contraceptives and other medications at the discretion of the
- •Investigator and/or Sponsor).
- •2. Use of over-the-counter medication within 7 days of the Day -1. Medications such as
- •paracetamol or non-steroidal anti-inflammatories and routinely taken dietary supplements
- •are allowed at the discretion of the Investigator and/or Sponsor.
- •3. Clinically significant abnormalities in laboratory results including:
- •a. Absolute neutrophil count (ANC) < 1.5 × 10^9/L;
- •b. Platelet count < 150 × 10^9/L;
- •c. Creatinine clearance (calculated by Cockcroft-Gault) < 60 mL/min;
- •d. Direct conjugated bilirubin >1.5 × upper limit of normal (ULN);
- •e. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × ULN;
- •f. Hemoglobin < 12 g/dL.
- •4. History of alcohol abuse or use of drugs of abuse in the 12 months prior to the Day -1.
- •Excess alcohol is defined as more than 14 drinks/week for women and 21 drinks/week for
- •men. A drink is defined as 360 mL of beer, 150 mL of wine, or 45 mL of spirits.
- •5. Females who are pregnant or breastfeeding.
- •6. Prior exposure to inclacumab or crizanlizumab.
- •7. Received an investigational drug within 30 days or 5 half-lives, whichever is longer, of
- •the Day -1, or is currently participating in another trial of an investigational or marketed
- •drug (or medical device).
- •8. Vaccination with live vaccine (with the exception of seasonal flu vaccine) within 6 weeks of Day -1 or planning for vaccination while participating in the study.
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