ACTRN12614000903684已完成1 期
A Randomized, Single-blind, Single-dose, 3-arm, Parallel Group Study to Determine the Pharmacokinetic Similarity of ABP 710 and Infliximab (Remicade 'Registered Trademark') in Healthy Adult Subjects
Amgen Inc, USA.0 个研究点目标入组 150 人开始时间: 2014年8月25日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- All
入选标准
- •Subjects must meet 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 performed.
- •2. Healthy male and female subjects between 18 to 45 years of age, inclusive, at the time of screening.
- •3. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, for non-Japanese subjects. A BMI between 18.0 and 25.0 kg/m2, inclusive, for Japanese subjects.
- •BMI = weight (kg)/(height [m])2
- •4. Normal or clinically acceptable physical examination, clinical laboratory test values, vital signs, and ECGs (12-lead ECG reporting heart rate and RR, PR, QRS, QT, and
- •QTc intervals) at screening (physical examination, vital signs, body weight and BMI, clinical laboratory tests, pregnancy test, urinalysis, urine drug screen, and alcohol
- •screen will be repeated on Day -1 and must also be normal or clinically acceptable).
- •5. Subjects must have up-to-date immunizations per local standards.
- •6. Subjects must be able to communicate effectively with the study personnel.
- •7. 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
排除标准
- •Exclusion criteria are as follows:
- •1. Women of childbearing potential or 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 for 6 months following treatment with the investigational product or until the scheduled EOS (whichever is longer).
- •2. Women planning to become pregnant during the study.
- •3. Men who are unwilling to refrain from donating sperm during the study or for 6 months following treatment with investigational product.
- •4. History or evidence of a clinically-significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator and Amgen medical
- •monitor or designee, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- •5. Evidence of recent (within 6 months) infection requiring in-patient hospitalization or IV antibiotics.
- •6. History of known positive tuberculin skin test or exposure to an individual with tuberculosis or positive QuantiFERON test (or equivalent) consistent with previous exposure to tuberculosis prior to or during the screening period (if not treated with appropriate chemoprophylaxis).
- •7. Tuberculosis or fungal infection seen on chest x-ray taken within 6 months of screening or during the screening period.
- •8. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- •9. Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer), prior to receiving investigational product.
- •10. Donated blood (including blood products) or experienced loss of blood (approximately 500 mL) within 2 months of screening.
- •11. Positive screen for alcohol and/or potential drugs of abuse (urine drug screen) at screening or prior to randomization.
- •12. Positive screen for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV).
- •13. History of alcohol and/or substance abuse within the last 12 months prior to screening.
- •14. Subjects who use > 10 cigarettes per day within the last 3 months or not able to abide by the smoking policy of the site.
- •15. Inability or unwillingness to reside at the CPU for 3 consecutive days (2 nights) or inability to be available for follow-up assessments or protocol-required procedures.
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