None listed
Conditions
Brief summary
The study will compare the safety, tolerability and pharmacokinetics (the levels of drug in the blood) of 3 drugs when given intravenously (into a vein). The drugs tested are: *a new drug called ABP 959, *a marketed drug called Eculizumab (Soliris registered trademark) approved in United States (US) *a marketed drug called Eculizumab (Soliris registered trademar) approved in European Union (EU) The study is to test that these drugs behave the same in the body, for example, produce the same drug levels in the blood. who is it for? You may be eligible to join this study if you are a healthy male 18 to 45 years of age, inclusive. 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. Trail Details Participants in this study will be randomly (by chance) allocated into one of three groups to receive either: - ABP 959 300 mg intravenously once only. - US approved Eculizumab 300 mg intravenously once only. - EU approved Eculizumab 300 mg intravenously once only. All participants will be followed-up at 50 days post allocation to one of the three drugs used in this trial.
Interventions
Arm 1: ABP 959 300 mg intravenously, final admixture concentration of 5 mg/mL
Arm 2: FDA-licensed eculizumab 300 mg intravenously, final admixture concentration of 5 mg/mL
Arm 3: EU-authorized eculizumab 300 mgintravenously, final admixture concentration of 5 mg/mL
Subjects will be randomized on Day -1 or prior to dosing on Day 1 according to a
computer-generated randomization schedule to receive either intravenous ABP 959 300 mg(treatment Arm 1) , Intravenous FDA-licensed eculizumab 300 mg (tr
Arm 1: ABP 959 300 mg intravenously, final admixture concentration of 5 mg/mL Arm 2: FDA-licensed eculizumab 300 mg intravenously, final admixture concentration of 5 mg/mL Arm 3: EU-authorized eculizumab 300 mgintravenously, final admixture concentration of 5 mg/mL Subjects will be randomized on Day -1 or prior to dosing on Day 1 according to a computer-generated randomization schedule to receive either intravenous ABP 959 300 mg(treatment Arm 1) , Intravenous FDA-licensed eculizumab 300 mg (treatment Arm 2), or Intravenous EU-authorized eculizumab 300 mg (treatment arm 3) in a ratio of 1:1:1, stratified by CPU and ethnicity (Japanese versus non-Japanese). Subjects will only be dosed once, on the morning of Day 1 over 35 minutes after breakfast.
Sponsors
Amgen Inc, USA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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 performed. 2. Healthy adult male subjects between 18 and 45 years of age, inclusive, at the time of screening. 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.
Exclusion criteria
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 abuse within the last 12 months prior to screening. 22. Subjects who use > 10 cigarettes per day within the last 3 months or not able to abide by the smoking policy of the site. 23. Inability or unwillingness to reside at the CPU for 2 consecutive days or inability to be available for follow-up assessments or protocol-required procedures, including Menactra registered trademark meningococcal vaccination (if subject is unable to show documentation of prior vaccination).
Outcome results
None listed