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Trial registered on ANZCTR


Registration number
ACTRN12614000903684
Ethics application status
Approved
Date submitted
4/08/2014
Date registered
25/08/2014
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 285034 0
Protocol Number: 20140108
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infliximab is currently used to treat patients with adult and pediatric inflammatory conditions. These inflammatory conditions affects various body systems such as gastrointestinal (Crohn’s disease). 292655 0
Infliximab is currently used to treat patients with adult and pediatric inflammatory conditions. These inflammatory conditions affects various body systems such as bowel (adult and pediatric ulcerative colitis). 292811 0
Infliximab is currently used to treat patients with adult and pediatric inflammatory conditions. These inflammatory conditions affects various body systems such as joints (rheumatoid arthritis). 292812 0
Infliximab is currently used to treat patients with adult and pediatric inflammatory conditions. These inflammatory conditions affects various body systems such as spine (ankylosing spondylitis). 292813 0
Infliximab is currently used to treat patients with adult and pediatric inflammatory conditions. These inflammatory conditions affects various body systems such as skin (psoriatic arthritis, and plaque psoriasis). 292814 0
Condition category
Condition code
Oral and Gastrointestinal 292968 292968 0 0
Crohn's disease
Inflammatory and Immune System 292969 292969 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289951 0
Treatment: Drugs
Comparator / control treatment
Food and Drug Administration (FDA)-licensed infliximab and EU authorized infliximab
Control group
Active

Outcomes
Primary outcome [1] 292826 0
The primary objective of this study is to determine the PK similarity (as assessed principally by AUCinf) of ABP 710 following a 5 mg/kg intravenous (IV) infusion relative to that of a 5 mg/kg IV infusion of
infliximab (US) or a 5 mg/kg IV infusion of infliximab (EU)

The outcome is assessed using a validated
electrochemiluminescent assay analysis
Timepoint [1] 292826 0
at 57 days after randomisation

Blood samples for serum ABP 710 concentration determination will be collected at predose, end of infusion (approximately 2 hours), 4, 8, 12, and 24 hours after the start of the infusion
Secondary outcome [1] 309760 0
To determine PK similarity (as assessed principally by AUCinf) of a 5 mg/kg IV infusion of infliximab (US) relative to a 5 mg/kg IV infusion of infliximab (EU)

This is assessed using a validated
electrochemiluminescent assay analysis
Timepoint [1] 309760 0
at 57 days after randomisation

Blood samples for serum infliximab concentration determination will be collected at predose, end of infusion (approximately 2 hours), 4, 8, 12, and 24 hours after the start of the infusion
Secondary outcome [2] 309761 0
To determine the safetyof ABP 710 in healthy adult subjects compared with infliximab (US) and infliximab (EU).
This is assessed using a validated
electrochemiluminescent assay analysis.
Timepoint [2] 309761 0
at 57 days after randomisation

Blood samples for safety determination will be collected at predose, end of infusion (approximately 2 hours), 4, 8, 12, and 24 hours after the start of the infusion
Secondary outcome [3] 309992 0
To determine the tolerability of ABP 710 in healthy adult subjects compared with infliximab (US) and infliximab (EU).
This is assessed using a validated
electrochemiluminescent assay analysis.
Timepoint [3] 309992 0
at 57 days after randomisation

Blood samples for safety determination will be collected at predose, end of infusion (approximately 2 hours), 4, 8, 12, and 24 hours after the start of the infusion
Secondary outcome [4] 309993 0
To determine the immunogenicity of ABP 710 in healthy adult subjects compared with infliximab (US) and infliximab (EU)
Timepoint [4] 309993 0
at 57 days after randomisation

Blood samples for safety determination will be collected at predose, end of infusion (approximately 2 hours), 4, 8, 12, and 24 hours after the start of the infusion. This is assessed using a validated electrochemiluminescent assay analysis

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through radio, print and television advertising and database searches. The Nucleus Network database currently has a number of Japanese and Caucasian volunteers. If required, print advertising may be used after translation to Japanese.
Through advertising, potential participants will contact the Nucleus Network volunteer recruitment office and a brief synopsis of the study and its requirements will be discussed over the telephone. Following this
initial telephone conversation, potential participants will be invited to the Centre for Clinical Studies.
The database searches will involve the volunteer recruitment officers identifying participants that are suitable for inclusion in the trial and contacting them by telephone. A brief synopsis of the study and its requirements will be discussed. Following this initial telephone
conversation, potential participants will be invited to the Centre for Clinical Studies. Volunteers registered on the databases have given consent to be contacted for future studies.
Participants will be provided with the information and consent form for this study by mail or email prior to attendance at the Centre for Clinical Studies where possible. Where this is not possible the information and
consent form will be provided in the privacy of a consulting room. The participant will be given the opportunity to take the information home before deciding to take part in the study or not. The information will be discussed with the potential participant and any questions answered by
the investigator and / or study staff.
When the participant is satisfied that they understand what their participation in the study involves, and they have had all their questions answered to their satisfaction, they will be asked to sign the consent form to participate in research, only if they are willing to participate. The
consenting process will be documented in the volunteers’ source documents.
Once the participant is deemed eligible, study treatment would be allocated by central randomisation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatment assigned will be decided by a code produced by a computer and will be decided at random (by chance, just like a roll of a dice). Allocation of a participant to the study will be performed by central randomisation by phone/fax/computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
At least 150 healthy adult male and female subjects will be enrolled in this study, of which a minimum of 24 Japanese subjects (8 per group) are required. Based on an assumption of between-subject variability (as measured by coefficient of variation) of 32% true geometric mean ratio (GMR) of 1 among ABP 710, infliximab (US), and
infliximab (EU), the resulting 90% confidence intervals (CIs) for the ratio of geometric means (ABP 710 to infliximab [US], ABP 710 to infliximab [EU], and infliximab [US] to
infliximab [EU]) for primary PK endpoints are estimated to fall entirely within margin (0.80, 1.25) with 90% power, assuming an approximate 10% dropout.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 2899 0
CMax
Recruitment hospital [2] 2900 0
Nucleus Network

Funding & Sponsors
Funding source category [1] 289710 0
Commercial sector/Industry
Name [1] 289710 0
Amgen Inc, USA.
Address [1] 289710 0
One Amgen Center Drive
MS 28-3-D
Thousand Oaks, CA 91320
Country [1] 289710 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Amgen Inc, USA.
Address
One Amgen Center Drive
MS 28-3-D
Thousand Oaks, CA 91320
Country
United States of America
Secondary sponsor category [1] 288406 0
None
Name [1] 288406 0
Address [1] 288406 0
Country [1] 288406 0
Other collaborator category [1] 278136 0
Commercial sector/Industry
Name [1] 278136 0
CMAX, a Division of IDT Australia Limited
Address [1] 278136 0
Level 5, East Wing Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, 5000
Country [1] 278136 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291450 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 291450 0
Commercial Road
Melbourne, 3004
Victoria
Ethics committee country [1] 291450 0
Australia
Date submitted for ethics approval [1] 291450 0
28/07/2014
Approval date [1] 291450 0
03/09/2014
Ethics approval number [1] 291450 0
Ethics committee name [2] 291546 0
Bellberry Human Research Ethics Committee
Ethics committee address [2] 291546 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [2] 291546 0
Australia
Date submitted for ethics approval [2] 291546 0
27/08/2014
Approval date [2] 291546 0
02/10/2014
Ethics approval number [2] 291546 0

Summary
Brief 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.

Trial website
Trial related presentations / publications
No presentations or publications have yet been released
Public notes

Contacts
Principal investigator
Name 50122 0
Dr Jason Lickliter
Address 50122 0
Nucleus Network Limited Centre for Clinical Studies (AMREP site) Level 5
Burnet Building 89 Commercial Road, Melbourne, Victoria 3004
Country 50122 0
Australia
Phone 50122 0
+61 3 9076 8960
Fax 50122 0
Email 50122 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 50123 0
Mr Jeffrey Wong
Address 50123 0
Nucleus Network Limited Centre for Clinical Studies (AMREP site) Level 5
Burnet Building 89 Commercial Road, Melbourne, Victoria 3004
Country 50123 0
Australia
Phone 50123 0
+61 3 9076 8909
Fax 50123 0
Email 50123 0
j.wong@nucleusnetwork.com.au
Contact person for scientific queries
Name 50124 0
Dr Jason Lickliter
Address 50124 0
Nucleus Network Limited Centre for Clinical Studies (AMREP site) Level 5
Burnet Building 89 Commercial Road, Melbourne, Victoria 3004
Country 50124 0
Australia
Phone 50124 0
+61 3 9076 8960
Fax 50124 0
Email 50124 0
j.lickliter@nucleusnetwork.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary