NCT01922336CompletedPhase 1
A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Samsung Bioepis Co., Ltd.
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Study Overview
Brief Summary
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy female subjects of non-childbearing potential and healthy male subjects
- •Have a body weight between 60.0 and 94.9 kg and a body mass index between 20.0 and 29.9 kg/m², inclusive.
Exclusion Criteria
- •history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IP formulation or comparable drugs.
- •active or latent Tuberculosis or who have a history of Tuberculosis.
- •history of invasive systemic fungal infections or other opportunistic infections
- •systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
- •serious infection associated with hospitalisation and/or which required intravenous antibiotics
- •history of and/or current cardiac disease
- •have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
- •Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.
Arms & Interventions
EU Remicade
Active Comparator
EU sourced Remicade (Reference drug)
Intervention: EU Remicade (Biological)
US Remicade
Active Comparator
US sourced Remicade (Reference drug)
Intervention: US Remicade (Biological)
SB2
Experimental
SB2 (Study drug)
Intervention: SB2 (Biological)
Outcomes
Primary Outcomes
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time Frame: 71 days
Maximum Serum Concentration (Cmax)
Time Frame: 71 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time Frame: 71 days
Secondary Outcomes
- Time to Cmax (Tmax)(71 days)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male SubjectsHealthyNCT02075073Samsung Bioepis Co., Ltd.109
Completed
Phase 1
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy SubjectsHealthyNCT02144714Samsung Bioepis Co., Ltd.189
Completed
Phase 1
Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male SubjectsHealthyNCT04514796Samsung Bioepis Co., Ltd.188
Unknown
Phase 3
Study of TQB2303 in Patients With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)Diffuse Large B-cell LymphomaNCT03777085Chia Tai Tianqing Pharmaceutical Group Co., Ltd.230
Completed
Phase 1
First Time in Human Study of ProtexiaIntervention for Nerve Agent ExposureNCT00744146PharmAthene, Inc.33