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

September 26, 2017 updated by: Samsung Bioepis Co., Ltd.

A Randomised, Open-label, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
SB4 (etanercept) 50 mg/mL PFS and AI
Drug: Etanercept
50 mg/mL PFS and AI
Experimental: Sequence 2
SB4 (etanercept) 50 mg/mL AI and PFS
Drug: Etanercept
50 mg/mL PFS and AI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCinf ACUinf
Time Frame: 56 days
Area under the concentration-time curve from time zero to infinity
56 days
AUClast
Time Frame: 56 days
Area under the concentration-time curve from time zero to the last quantifiable concentration
56 days
Cmax
Time Frame: 56 days
Maximum serum concentration
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2017

Primary Completion (Actual)

August 7, 2017

Study Completion (Actual)

August 7, 2017

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB4-G12-NHV
  • 2016-004993-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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