MedTrace Logo

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

NCT03193203 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-09-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Etanercept

50 mg/mL PFS and AI

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2017-08-07
Completion
2017-08-07

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193203 on ClinicalTrials.gov