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

NCT ID: NCT03193203

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-24

Study Completion Date

2017-08-07

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sequence 1

SB4 (etanercept) 50 mg/mL PFS and AI

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

50 mg/mL PFS and AI

Sequence 2

SB4 (etanercept) 50 mg/mL AI and PFS

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

50 mg/mL PFS and AI

Interventions

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Etanercept

50 mg/mL PFS and AI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PRA Health Sciences

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2016-004993-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SB4-G12-NHV

Identifier Type: -

Identifier Source: org_study_id