Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

NCT01922336 | Completed Phase 1 Results

• 2 other identifiers: SB2-G11-NHV2012-005306-22
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

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

  71 days

• Maximum Serum Concentration (Cmax)

  71 days

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

  71 days

Secondary Outcomes (1)

• Time to Cmax (Tmax)

  71 days

Study Arms (3)

SB2

EXPERIMENTAL

SB2 (Study drug)

Biological: SB2

EU Remicade

ACTIVE COMPARATOR

EU sourced Remicade (Reference drug)

Biological: EU Remicade

US Remicade

ACTIVE COMPARATOR

US sourced Remicade (Reference drug)

Biological: US Remicade

Interventions

SB2 BIOLOGICAL

IV infusion

SB2

EU Remicade BIOLOGICAL

IV infusion

EU Remicade

US Remicade BIOLOGICAL

IV infusion

US Remicade

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects of non-childbearing potential and healthy male subjects
• Have a body weight between 60.0 and 94.9 kg and 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 IP 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 30 days 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 1 month or 10 half-lives of the medication prior to the administration of investigational product.

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (1)

Parexel International GmbH

Berlin, Germany

Location

Related Publications (1)

• Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015 Dec;29(6):381-8. doi: 10.1007/s40259-015-0150-5.

  PMID: 26577771 DERIVED

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd.

sbregistry@samsung.com

+82 31 8061 4534

Study Officials

• Rainard Fuhr, M.D., Ph.D.

  Parexel

  PRINCIPAL INVESTIGATOR

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: August 12, 2013
• First Posted: August 14, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 21, 2019
• Results First Posted: February 21, 2019

Record last verified: 2018-10

Locations

DE (1)