ACTRN12616000093482招募中2 期
A single dose, randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics and pharmacodynamics of M012 administered by subcutaneous injection to healthy male volunteers
Merganser Biotech Australia Pty Ltd.0 个研究点目标入组 56 人开始时间: 2016年1月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
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
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •1.Be a healthy male volunteer age 18-60.
- •2.Have a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive).
- •3.Have laboratory values within the reference range unless deemed not clinically significant by the Investigator.
- •4.Be surgically sterile, using barrier method of contraception or abstain from sexual intercourse from inpatient admission to one month after dosing.
- •5.Agree to adhere to the protocol-defined schedule of assessments and procedures.
- •6.Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
排除标准
- •1.Have iron deficiency, iron overload, liver disease, renal disease, chronic inflammatory disease, haemochromatosis, beta thalassemia, glucose 6 phosphate dehydrogenase deficiency or hemolytic anaemia.
- •2.Be a current smoker.
- •3.Have alcohol intake outside normal limits (> an average of 3 standard drinks per day).
- •4.Have received a blood transfusion within the last 3 months.
- •5.Have positive test result for human immunodeficiency virus (HIV).
- •6.Have positive test result for hepatitis B surface antigen, or hepatitis C antibody.
- •7.Have donated blood within 4 weeks of screening.
- •8.Have had recent (within 4 weeks of screening) significant (greater than or equal to 1 unit) blood loss for any reason.
- •9.Have any evidence of abnormal iron metabolism. During screening, the following indicators must all be within normal limits: Hb, RBC, reticulocyte count, RDW, haematocrit, TSAT, serum ferritin, serum iron and TIBC.
- •10.Have participated in an investigational drug trial within 30 days prior to first dose of study drug on Day 1.
- •11.Have a known hypersensitivity to any ingredient in the study formulation.
- •12.Have, as determined by the Investigator and/or medical monitor, any clinically relevant medical or surgical condition that could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
研究者
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