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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Etanercept

• Registration Number: NCT03193203
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-24
• Status Verified: 2017-06
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Primary Completion: 2017-08-07
• Study Completion: 2017-08-07
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	Etanercept	SB4 (etanercept) 50 mg/mL PFS and AI
Sequence 2	Etanercept	SB4 (etanercept) 50 mg/mL AI and PFS

Primary Outcome Measures

Name	Time	Method
Cmax	56 days	Maximum serum concentration
AUCinf ACUinf	56 days	Area under the concentration-time curve from time zero to infinity
AUClast	56 days	Area under the concentration-time curve from time zero to the last quantifiable concentration

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands