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

Samsung

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: SB3; Biological: US sourced Herceptin®; Biological: EU sourced Herceptin®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02075073

SB3-G11-NHV

2013-004112-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

109 participants in 3 patient groups

SB3

Experimental group

Description:

SB3, single dose of 6 mg/kg via intravenous infusion (study drug)

Treatment:

Biological: SB3

EU sourced Herceptin®

Active Comparator group

Description:

EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)

Treatment:

Biological: EU sourced Herceptin®

US sourced Herceptin®

Active Comparator group

Description:

US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)

Treatment:

Biological: US sourced Herceptin®