Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326233
• Other study ID #: SB5-G12-NHV
• Secondary ID: 2014-005178-12
• Status: Completed
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2018
• 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 pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

• Have a body mass index between 20.0 to 29.9 kg/m², inclusive.

Exclusion Criteria:

• History and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference investigational product formulation or comparable drugs

• Active or latent Tuberculosis or who have a history of Tuberculosis

• History of invasive systemic fungal infections or other opportunistic infections

• Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process

• Serious infection associated with hospitalisation and/or which required intravenous antibiotics

• History of and/or current cardiac disease

• Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the subject's last visit

• Intake medication with a half-life > 24 h within 4 weeks or 10 half-lives of the medication prior to investigational product administration

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Pen of SB5

• PFS of SB5

Locations

Country	Name	City	State
Belgium	Samsung Investigational Site	Antwerpen
New Zealand	Samsung Investigational Site	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Belgium,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)		0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Primary	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)		0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Primary	Maximum Serum Concentration (Cmax)		0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
Secondary	Time to Reach Cmax (Tmax)		0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose