NCT02075073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 29, 2016

Completed
Last Updated

September 14, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

February 27, 2014

Results QC Date

August 5, 2016

Last Update Submit

August 16, 2017

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)

    57 days

  • Maximum Serum Concentration (Cmax)

    57 days

  • Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

    57 days

Secondary Outcomes (1)

  • Time to Cmax (Tmax)

    57 days

Study Arms (3)

SB3

EXPERIMENTAL

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

Biological: SB3

EU sourced Herceptin®

ACTIVE COMPARATOR

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

Biological: EU sourced Herceptin®

US sourced Herceptin®

ACTIVE COMPARATOR

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

Biological: US sourced Herceptin®

Interventions

SB3BIOLOGICAL
SB3
EU sourced Herceptin®BIOLOGICAL
EU sourced Herceptin®
US sourced Herceptin®BIOLOGICAL
US sourced Herceptin®

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Investigational Site

Berlin, Germany

Location

Related Publications (1)

  • Pivot X, Curtit E, Lee YJ, Golor G, Gauliard A, Shin D, Kim Y, Kim H, Fuhr R. A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects. Clin Ther. 2016 Jul;38(7):1665-1673.e3. doi: 10.1016/j.clinthera.2016.06.002. Epub 2016 Jun 29.

    PMID: 27368117DERIVED

Results Point of Contact

Title
Director, Clinical Development
Organization
Samsung Bioepis
+82 31 8061 4534

Study Officials

  • Saumsung Bioepis

    Samsung Bioepis Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 14, 2017

Results First Posted

September 29, 2016

Record last verified: 2017-08

Locations

DE(1)