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

Samsung

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: US sourced Enbrel; Biological: SB4; Biological: EU sourced Enbrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01865552

SB4-G11-NHV

2012-004371-39 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 138 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

138 participants in 6 patient groups

SB4 and EU sourced Enbrel in Part A

Experimental group

Description:

SB4 followed by EU sourced Enbrel

Treatment:

Biological: SB4

Biological: EU sourced Enbrel

EU sourced Enbrel and SB4 in Part A

Experimental group

Description:

EU sourced Enbrel followed by SB4

Treatment:

Biological: SB4

Biological: EU sourced Enbrel

SB4 and US sourced Enbrel in Part B

Experimental group

Description:

SB4 followed by US sourced Enbrel

Treatment:

Biological: US sourced Enbrel

Biological: SB4

US sourced Enbrel and SB4 in Part B

Experimental group

Description:

US sourced Enbrel followed by SB4

Treatment:

Biological: US sourced Enbrel

Biological: SB4

EU and US sourced Enbrel in Part C

Other group

Description:

EU sourced Enbrel followed by US sourced Enbrel

Treatment:

Biological: US sourced Enbrel

Biological: EU sourced Enbrel

US and EU sourced Enbrel in Part C

Other group

Description:

US sourced Enbrel followed by EU sourced Enbrel

Treatment:

Biological: US sourced Enbrel

Biological: EU sourced Enbrel