Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

A Randomised, Single-blind, Three-part, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Three Formulations of Etanercept (SB4, EU Sourced Enbrel® and US Sourced Enbrel®) in Healthy Male Subjects

The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: SB4; Biological: EU sourced Enbrel; Biological: US sourced Enbrel

Detailed Description

• Part A: Comparison between SB4 and EU sourced Enbrel
• Part B: Comparison between SB4 and US sourced Enbrel
• Part C: Comparison between EU sourced Enbrel and US sourced Enbrel

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects
• Have a body weight between 60 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 TB.
• 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 first administration of IP.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB4 and EU sourced Enbrel in Part A; SB4 followed by EU sourced Enbrel	Biological: SB4; SC administration; Biological: EU sourced Enbrel; SC administration
Experimental: EU sourced Enbrel and SB4 in Part A; EU sourced Enbrel followed by SB4	Biological: SB4; SC administration; Biological: EU sourced Enbrel; SC administration
Experimental: SB4 and US sourced Enbrel in Part B; SB4 followed by US sourced Enbrel	Biological: SB4; SC administration; Biological: US sourced Enbrel; SC administration
Experimental: US sourced Enbrel and SB4 in Part B; US sourced Enbrel followed by SB4	Biological: SB4; SC administration; Biological: US sourced Enbrel; SC administration
Other: EU and US sourced Enbrel in Part C; EU sourced Enbrel followed by US sourced Enbrel	Biological: EU sourced Enbrel; SC administration; Biological: US sourced Enbrel; SC administration
Other: US and EU sourced Enbrel in Part C; US sourced Enbrel followed by EU sourced Enbrel	Biological: EU sourced Enbrel; SC administration; Biological: US sourced Enbrel; SC administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose	0 to 480 hours post-dose
Maximum Serum Concentration (Cmax)	pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.	0 to 480 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose	0 to 480 hours post-dose
Time to Cmax (Tmax)	pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose	0 to 480 hours post-dose

Collaborators and Investigators

• Sponsor: Samsung Bioepis Co., Ltd.
• Investigators: Principal Investigator: Rainard Fuhr, M.D., Ph.D., Parexel

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 2, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: SB4-G11-NHV; 2012-004371-39 (EudraCT Number)