A Randomized, Single-Blind, Single-Dose, 3-Arm, Parallel Group Study to Determine the Pharmacokinetic Equivalence of ABP 980 and Trastuzumab (Herceptin (Registered Trademark) ) in Healthy Male Subjects

Amgen Inc, USA.0 个研究点目标入组 150 人开始时间: 2014年4月14日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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 adult men between 18 to 45 years of age, inclusive.
•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, echocardiogram, and electrocardiograms (ECGs; 12-lead ECG reporting heart rate and RR, PR, QRS, QT, and QTcF intervals) at screening (physical examination, ECGs, and vital signs will be repeated on Day -1).
•5. Subjects must be able to communicate effectively with the study personnel.
•6. To be enrolled as a Japanese subject, subjects must be either first- or second-generation
•- 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.

•1. Men of reproductive potential (ie, men who have not had a vasectomy), unwilling to practice a highly effective method of birth control for the duration of the study and continuing 5 months following treatment with investigational product. Highly effective methods of birth control include:
•a. sexual abstinence;
•b. 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 5 months following treatment with investigational product.
•3. Men with pregnant partners.
•4. History or evidence of a clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
•5. History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs.
•6. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
•7. Positive screen for alcohol and/or potential drugs of abuse at screening or prior to randomization.
•8. Positive screen for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).

发起方

Amgen Inc, USA.