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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Pen of SB5; Biological: PFS of SB5

• Registration Number: NCT02326233
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2014-12-26
• Study First Posted: 2014-12-29
• Study Start: 2015-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2018-05-14
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Results First Posted: 2019-03-18
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pen of SB5	Pen of SB5	Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug)
PFS of SB5	PFS of SB5	PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

Primary Outcome Measures

Name	Time	Method
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
Maximum Serum Concentration (Cmax)	0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Investigational Site; 🇳🇿 Auckland, New Zealand