CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 190 enrolled
Drug / intervention
Pen of SB5 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02326233
NCT02326233Phase 1Completed
CompareCT.gov

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

Samsung Bioepis Co., Ltd.·interventional·Posted Dec 29, 2014·Updated Mar 18, 2019

In Brief

A Phase 1 clinical trial evaluating Pen of SB5 and PFS of SB5 for Healthy. Completed, enrolled 190 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBelgium, New Zealand
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 29, 2014
Enrollment StartJun 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.5 years ago

Interventions

Pen of SB5biological

PFS of SB5biological