Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: SB2; Biological: US Remicade; Biological: EU Remicade

• Registration Number: NCT01922336
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-14
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2018-10
• Results First Submitted: 2018-10-11
• Results First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Results First Posted: 2019-02-21
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB2	SB2	SB2 (Study drug)
US Remicade	US Remicade	US sourced Remicade (Reference drug)
EU Remicade	EU Remicade	EU sourced Remicade (Reference drug)

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	71 days
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	71 days
Maximum Serum Concentration (Cmax)	71 days

Secondary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax)	71 days

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany