NCT02326233

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

A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Pen of SB5
BIOLOGICAL	PFS of SB5

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-12-29
• Last updated: 2019-03-18
• Results posted: 2019-03-18

Locations

2 sites across 2 countries: Belgium, New Zealand