Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: US sourced Herceptin®; Biological: SB3; Biological: EU sourced Herceptin®

• Registration Number: NCT02075073
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2016-08-05
• Results First Submitted QC: 2016-08-05
• Results First Posted: 2016-09-29
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 109

Inclusion Criteria

• Healthy male subjects
• Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and 29.9 kg/m², inclusive.

Exclusion Criteria

• history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or significant allergic disease excluding mild asymptomatic allergies.
• history of and/or current cardiac disease
• previously received any monoclonal antibody or fusion protein.
• history of cancer including lymphoma, leukaemia and skin cancer.
• Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
• intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US sourced Herceptin®	US sourced Herceptin®	US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
SB3	SB3	SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
EU sourced Herceptin®	EU sourced Herceptin®	EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)	57 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)	57 days
Maximum Serum Concentration (Cmax)	57 days

Secondary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax)	57 days

Trial Locations

Locations (1)

Samsung Investigational Site; 🇩🇪 Berlin, Germany