Trial Details
Not RecruitingBasic Information
| Clinical ID | c5494 |
|---|---|
| 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 | NULL |
|---|---|
| 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 ad |
| 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), |
Participant Information
| Sponsor | Amgen Inc, USA. |
|---|---|
| City | NULL |
| Country/Region | Australia |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | PHASE1 |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |