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

S

Samsung

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Biological: SB2
Biological: US Remicade
Biological: EU Remicade

Study type

Interventional

Funder types

Industry

Identifiers

NCT01922336
SB2-G11-NHV
2012-005306-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

159 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

159 participants in 3 patient groups

SB2
Experimental group
Description:
SB2 (Study drug)
Treatment:
Biological: SB2
EU Remicade
Active Comparator group
Description:
EU sourced Remicade (Reference drug)
Treatment:
Biological: EU Remicade
US Remicade
Active Comparator group
Description:
US sourced Remicade (Reference drug)
Treatment:
Biological: US Remicade

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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