Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Samsung

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT03193203

2016-004993-16 (EudraCT Number)

SB4-G12-NHV

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.

Enrollment

50 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects aged 18-55 years
Have a body weight between 60.0 - 85.5 kg (inclusive) and a body mass index between 20.0 - 28.0 kg/m2 (inclusive)

Exclusion criteria

Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient
Have either active or latent TB or who have a history of TB
Have clinically significant active infection within 4 weeks before the first IP administration
Have had a history of serious infection
Have previously been exposed to etanercept, if known
Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration
Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator