ACTRN12613000374763招募中1 期
A Phase 1 single-blind, single-treatment, pharmacodynamic and pharmacokinetic study of ZY7318 (pegylated recombinant human erythropoietin) in thirty two(32) healthy adult male volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
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 45 Years（—）
- 性别
- Male
入选标准
- •1.Able to provide written Informed Consent;
- •2.Ability to communicate effectively with study personnel;
- •3.Willingness to adhere to the protocol requirements;
- •4.Male healthy volunteers;
- •5.Age greater than or equal to 18 years and less than or equal to 45 years;
- •6.Body Mass Index=20-=30 kg/m2.
- •7.In good general health with no clinically significant illness seen on physical examination or ongoing medical history,as determined by the Investigator;
- •8.Documented 12 lead ECG with no clinically significant abnormalities, as determined by the Investigator;
- •9.No clinically significant abnormalities in screening or Day-1 laboratory tests, as determined by the Investigator;
- •10.Hemoglobin between 12-17g/dL.
排除标准
- •1.Any prior treatment with Erythropoiesis-Stimulating Agents (ESAs);
- •2.History of hypersensitivity to erythropoietin or any related drug;
- •3.Active liver disease and/or liver transaminases greater than 1.5X upper limit of normal;
- •4.History of anemia;
- •5.History or presence of blood dyscrasias (e.g. thrombocytopenia, neutropenia);
- •6.History or presence of thyroid disorders;
- •7.History of presence of pulmonary disorders (e.g. dyspnea, pneumonia);
- •8.History or presence of autoimmune disorders (e.g. thyroiditis, rheumatoid arthritis);
- •9.History or presence of arrhythmia or any other cardiovascular disease
- •10.Subjects taking drugs that have a narrow therapeutic index(e.g.anti-epileptics,etc.)and drugs that can depress the immune system(e.g. anti-cancer drugs, etc.);
- •11.Blood pressure less than 90/60 (Systolic/diastolic)mm Hg or more than 140/90 mm Hg;
- •12.Febrile;
- •13.Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator;
- •14.Donated blood within 60 days of screening or otherwise experienced blood loss of>250mL within the same period;
- •15.Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug;
- •16.Received or intending to receive a vaccination in the two weeks prior to dosing, or any time during study participation;
- •17.Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment;
- •18.History of drug and/or alcohol dependence within past 12 months,and/or positive results on drug of abuse or alcohol tests;
- •19.Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency;
- •20.Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination;
- •21.Has taken any regular,prescribed,or over-the-counter medication with the exception of acetaminophen (maximum2g/day) or multi-vitamins in the two weeks prior to dosing(other medication may only be taken with the specific approval of the Investigator in consultation with the Medical Monitor);
- •22.Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri;
- •23.Unable to comply with study attendance, protocol procedures or other study requirements;
- •24.Any condition that, in the opinion of the investigator, might interfere with study objectives.
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