Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: EU sourced Humira®; Biological: SB5; Biological: US sourced Humira®

• Registration Number: NCT02144714
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-22
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2018-01-11
• Results First Submitted QC: 2018-01-11
• Results First Posted: 2018-09-21
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Healthy subjects
• Have 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 investigational product 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 4 weeks 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 4 weeks or 10 half-lives of the medication prior to investigational product administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US sourced Humira®	EU sourced Humira®	US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5	SB5	SB5, single dose of 40 mg via subcutaneous injection (study drug)
EU sourced Humira®	SB5	EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
EU sourced Humira®	US sourced Humira®	EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)
SB5	EU sourced Humira®	SB5, single dose of 40 mg via subcutaneous injection (study drug)
US sourced Humira®	US sourced Humira®	US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	0 to 1680 hours post-dose	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	0 to 1680 hours post-dose	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose
Maximum Serum Concentration (Cmax)	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

Secondary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax)	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose	pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

Trial Locations

Locations (1)

Samsung Investigational Site; 🇩🇪 Berlin, Germany