Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Samsung

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: Pen of SB5

Biological: PFS of SB5

Study type

Interventional

Funder types

Industry

Identifiers

NCT02326233

2014-005178-12 (EudraCT Number)

SB5-G12-NHV

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

Enrollment

190 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subjects
Have a body mass index between 20.0 to 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 subject's last visit
Intake medication with a half-life > 24 h within 4 weeks or 10 half-lives of the medication prior to investigational product administration