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.
150 participants
Oct 6, 2014
Interventional
Conditions
Summary
The study is evaluating the safety, tolerability, and immunogenicity of ABP 710 in healthy subjects compared with US Food and Drug Administration (FDA)-licensed Infliximab and European Union (EU)-authorized Infliximab. Who is it for? You may be eligible to join this study if you are a healthy male and female subjects 18 to 45 years of age, inclusive. Non-Japanese subjects will have a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Japanese subjects must be first- or second-generation Japanese and have a BMI of 18.0 to 25.0 kg/m2, inclusive. Trial details Participants in this study will be randomly (by chance) divided into one of three groups. Participants in one group will receive 5mg/kg of ABP 710 (100mg vial) intravenously once only. Participants in the second group will receive 5mg/kg2 of FDA-licensed Infliximab (100mg vial) intravenously. Participants in the third group will receive 5mg/kg2 of EU-authorised Infliximab (100mg vial) intravenously. All participants will be followed-up at 57 days post allocation to one of the three drugs used in this trial.
Eligibility
Inclusion Criteria12
- Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures are performed.
- Healthy male and female subjects between 18 to 45 years of age, inclusive, at the time of screening.
- 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
- 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).
- Subjects must have up-to-date immunizations per local standards.
- Subjects must be able to communicate effectively with the study personnel.
- 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
Exclusion Criteria17
- 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).
- Women planning to become pregnant during the study.
- Men who are unwilling to refrain from donating sperm during the study or for 6 months following treatment with investigational product.
- 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.
- Evidence of recent (within 6 months) infection requiring in-patient hospitalization or IV antibiotics.
- 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).
- Tuberculosis or fungal infection seen on chest x-ray taken within 6 months of screening or during the screening period.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- 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.
- Donated blood (including blood products) or experienced loss of blood (approximately 500 mL) within 2 months of screening.
- Positive screen for alcohol and/or potential drugs of abuse (urine drug screen) at screening or prior to randomization.
- Positive screen for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV).
- History of alcohol and/or substance abuse within the last 12 months prior to screening.
- Subjects who use > 10 cigarettes per day within the last 3 months or not able to abide by the smoking policy of the site.
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Arm 1: ABP 710 5 mg/kg (100 mg vial) Arm 2: infliximab 5 mg/kg (FDA-licensed 100 mg vial) Arm 3: infliximab 5 mg/kg (EU-authorized; 100 mg vial) Subjects will be randomised to receive intravenous infusion of ABP 710 5 mg/kg (Treatment Arm 1), infliximab 5 mg/kg (FDA-licensed; Treatment Arm 2), or infliximab 5 mg/kg (EU-authorized; Treatment Arm 3) in a ratio of 1:1:1 stratified by ethnicity (Japanese versus non- Japanese). Subjects will only be dosed once, on the morning of Day 1 over 2 hours after breakfast. Weight from Day -1 will be used to calculate dose.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000903684