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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193203
• Other study ID #: SB4-G12-NHV
• Secondary ID: 2016-004993-16
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2017
• Last updated: September 26, 2017
• Start date: March 24, 2017
• Est. completion date: August 7, 2017

Study information

• Verified date: June 2017
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Etanercept
50 mg/mL PFS and AI

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf ACUinf	Area under the concentration-time curve from time zero to infinity	56 days
Primary	AUClast	Area under the concentration-time curve from time zero to the last quantifiable concentration	56 days
Primary	Cmax	Maximum serum concentration	56 days