ACTRN12616000509460已完成1 期
A Randomized, Double-Blind, Single-Dose, 3-Arm, Parallel Group Study to Determine the Pharmacokinetic Similarity of ABP 959 and Eculizumab (Soliris Registered Trademark) in Healthy Male Subjects
Amgen Inc, USA0 个研究点目标入组 210 人开始时间: 2016年4月20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
- 210
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
- •Subjects must meet all inclusion criteria to be eligible for study participation.
- •1. Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee
- •(IEC) approved informed consent form (ICF) before any study-specific procedures are
- •2. Healthy adult male subjects between 18 and 45 years of age, inclusive, at the time of
- •3. Non-Japanese subjects will have a BMI of 18.0 to 30.0 kg/m2, inclusive, at screening and check-in. Japanese subjects must have a BMI of 18.0 to 25.0 kg/m2, inclusive, at screening and check-in. BMI equals weight (kg)/(height [m])2
- •4. Subjects will have a body weight of 50.0 to 90.0 kg, inclusive.
- •5. To be enrolled as a Japanese subject, subjects must be either first- or second-generation Japanese:
- •*First-generation Japanese are subjects who may be living outside of Japan but
- •were born in Japan to parents of Japanese descent.
- •*Second-generation Japanese are subjects who were born outside of Japan to
- •first-generation Japanese parents.
- •6.Normal or clinically acceptable physical examination, clinical laboratory test values,
- •urinalysis values, vital signs, ECGs (12-lead ECG reporting heart rate and RR, PR, QRS, QT,
- •and QTc intervals), and body weight, as determined by the investigator, at all predose
- •assessments (ie, screening, Day -1, and predose on Day 1).
- •7.Negative urine drug screen and alcohol screen at screening and Day -1.
- •8.Subjects must be able to communicate effectively with the study personnel.
排除标准
- •1. Men of reproductive potential (ie, men who have not had a vasectomy) who are unwilling to practice a highly effective method of birth control for the duration of the study and continuing 6 months following treatment with IP. Highly effective methods of birth control include:
- •*Sexual abstinence
- •* Vasectomy or a condom (men) in combination with either barrier methods, hormonal
- •birth control, or intrauterine device (utilized by female partners)
- •2. Men who are unwilling to refrain from donating sperm during the study and for 6 months following treatment with IP.
- •3. Men with pregnant partners.
- •4. Hypertension (defined as a systolic blood pressure > 140 mmHg and/or a diastolic blood pressure > 90 mmHg confirmed by a single repeat measurement that same day) or a history of hypertension requiring intervention.
- •5. Proteinuria (with a urine dipstick value of 2+ or above) at screening or check-in.
- •6. Coagulation abnormalities (ie, international normalized ratio [INR] > 2 x upper limit of
- •normal) at screening or check-in.
- •7. Known or suspected hereditary complement deficiency.
- •8. Presence or suspicion of active bacterial infection, in the opinion of the investigator.
- •9. History of meningococcal infection.
- •10. History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator and ICON Medical Monitor or designee, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- •11. History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs.
- •12. Use of any over the counter (OTC) or prescription medications within the 14 days or
- •5 half-lives (whichever is longer), prior to receiving IP. Acetaminophen (up to 2 g per day
- •and not more than 4 g per week) for analgesia will be allowed. Vitamin use can be allowed per agreement between Amgen Inc and the medical monitor.
- •13. All herbal medicines (eg, St. John’s wort) and supplements consumed by the subject within the 30 days prior to receiving IP, and continuing use if applicable, will be reviewed by the investigator and the ICON Medical Monitor. Written documentation of this review and Amgen acknowledgment of the decision made with respect to eligibility is required for subject participation.
- •14. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- •15. Receiving or has received other investigational drugs (or is currently using an investigational device) within 30 days or 5 half-lives (whichever is longer) prior to receiving IP.
- •16. Prior exposure to eculizumab or related compounds (ie, a monoclonal antibody that
- •specifically binds to the complement protein C5).
- •17. Known or suspected sensitivity to products derived from mammalian cell lines.
- •18. Donated blood (including blood products) or experienced loss of blood = 500 mL within 2 months of screening.
- •19. Positive screen for alcohol and/or potential drugs of abuse (urine drug screen) at screening or upon admission to the CPU (Day -1). Subject should refrain from drinking alcohol within 72 hours prior to screening and Day -1, and should not consume alcohol throughout the study.
- •20. Positive screen for human immunodeficiency virus (HIV1 and 2), hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (HBcAb; immunoglobulin M test only), or hepatitis C virus (HCV).
- •21. History of alcohol and/or substance ab
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