ISRCTN80902301已完成1 期
A phase I double-blind, randomised, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and immunogenicity of PolyCAb in healthy subjects following single doses and one cohort of multiple dosing
MicroPharm Limited0 个研究点目标入组 18 人开始时间: 2016年2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
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy male and female subjects between 18 and 70 years of age. At least 2 subjects in each cohort should be > 60 years of age. (added 30/09/2016)
- •2. Female subjects of non-child bearing potential with negative pregnancy test at screening visit (to be confirmed prior to first dose)
- •3. Male subject willing to use two effective methods of contraception (unless anatomically sterile or abstaining as preferred and usual lifestyle)
- •4. Body Mass Index between 18.5 and 30
- •5. No clinically significant abnormal serum biochemistry, haematology and urine levels measured within 28 days of the first dose
- •6. Negative results for urinary drugs of abuse screen, determined within 28 days of the first dose (a positive alcohol test may be repeated at the discretion of the Investigator)
- •7. Negative HIV and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results
- •8. No clinically significant abnormalities in vital signs (blood pressure, pulse, respiration rate and oral temperature) determined within 28 days of the first dose
- •9. No clinically significant abnormalities in 12-lead ECG determined within 28 days of the first dose
- •10. Available to complete the study (including all follow-up visits)
- •11. Subject must satisfy a medical examiner about their fitness to participate in the study
- •12. Subject must provide written informed consent to participate
排除标准
- •1. Receipt of regular prescription and / or OTC medication within 28 days of the first dose that may have an impact on the safety and objectives of the study (at the Investigator’s discretion)
- •2. Subjects with any clinically significant disease including but not limited to cardiovascular, respiratory, metabolic, immunologic, hepatic, renal, endocrinal, neurologic, skin or psychiatric disease
- •3. Subject with a current or past history of any psychological or psychiatric disorders
- •4. Evidence of gastrointestinal, renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction
- •5. Subjects with allergy/ hypersensitivity to any medication including marketed, unmarketed or OTC medications. Any clinically significant findings at planned site of infusion, including dark skin, tattoos or veins not suitable for venepuncture.
- •6. A clinically significant allergic disease (excluding non-active seasonal allergy)
- •7. A clinically significant history of drug or alcohol abuse in past 3 years
- •8. Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function)
- •9. Participation in a clinical study or receipt of treatment with any ovine antibodies or other ovine serum constituents
- •10. Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the previous 30 days (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study)
- •11. Donation of 450 mL or more blood within the previous 3 months
- •12. Vaccination within the previous 3 months which may have an impact on the safety or objectives of the study (at the Investigator’s discretion)
- •To be confirmed at Baseline / Prior to First Dose:
- •1. Development of any exclusion criteria since the Screening Visit
- •2. Receipt of any medication since the Screening Visit that may have an impact on the safety and objectives of the study (at the Investigator’s discretion)
研究者
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