NCT02144714

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

November 14, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

May 20, 2014

Results QC Date

January 11, 2018

Last Update Submit

October 15, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

    pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

    0 to 1680 hours post-dose

  • Maximum Serum Concentration (Cmax)

    pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

    pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

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

    pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

    0 to 1680 hours post-dose

Secondary Outcomes (1)

  • Time to Cmax (Tmax)

    pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose

Study Arms (3)

SB5

EXPERIMENTAL

SB5, single dose of 40 mg via subcutaneous injection (study drug)

Biological: SB5Biological: EU sourced Humira®

EU sourced Humira®

ACTIVE COMPARATOR

EU sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

Biological: SB5Biological: US sourced Humira®

US sourced Humira®

ACTIVE COMPARATOR

US sourced Humira®, single dose of 40 mg via subcutaneous injection (reference drug)

Biological: EU sourced Humira®Biological: US sourced Humira®

Interventions

SB5BIOLOGICAL
EU sourced Humira®SB5
EU sourced Humira®BIOLOGICAL
SB5US sourced Humira®
US sourced Humira®BIOLOGICAL
EU sourced Humira®US sourced Humira®

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects
  • Have a body mass index between 20.0 and 29.9 kg/m², inclusive.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Investigational Site

Berlin, Germany

Location

Related Publications (1)

  • Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

    PMID: 33263165DERIVED

Results Point of Contact

Title
Samsung Bioepis
Organization
Samsung Bioepis
sbregistry@samsung.com
+82 31 8061 4534

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 14, 2018

Results First Posted

September 21, 2018

Record last verified: 2018-10

Locations

DE(1)