Trial Details

Not Recruiting
Basic Information
Clinical ID c3057
Identifier ACTRN12614000903684
Trial 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
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions 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).;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).;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).;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).;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). ; 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). 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). 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). 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). Infliximab is currently used to treat patients with adult and pediatric inflammatory conditions. These inflammatory conditions affects various body systems ;Oral and Gastrointestinal - Crohn's disease;Inflammatory and Immune System - Other inflammatory or immune system disorders
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.
Participant Information
Sponsor Amgen Inc, USA.
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -