Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects


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This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Samsung Bioepis Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03193203

First received: June 19, 2017

Last updated: June 19, 2017

Last verified: June 2017

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the autoinjector and pre-filled syringe of SB4 in healthy male subjects.

Healthy Drug: Etanercept Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Other
Official Title: A Randomised, Open-label, Two-period, Two-sequence, Single-dose, Cross-over Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Primary Outcome Measures:

  • AUCinf ACUinf [ Time Frame: 56 days ]

    Area under the concentration-time curve from time zero to infinity

  • AUClast [ Time Frame: 56 days ]

    Area under the concentration-time curve from time zero to the last quantifiable concentration

  • Cmax [ Time Frame: 56 days ]

    Maximum serum concentration

Enrollment: 50
Actual Study Start Date: April 17, 2017
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Experimental: Sequence 1

SB4 50 mg/mL PFS and AI

Drug: Etanercept

50 mg/mL PFS and AI

Experimental: Sequence 2

SB4 50 mg/mL AI and PFS

Drug: Etanercept

50 mg/mL PFS and AI

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male subjects aged 18-55 years
  • Have a body weight between 60.0 – 85.5 kg (inclusive) and a body mass index between 20.0 – 28.0 kg/m2 (inclusive)

Exclusion Criteria:

  • Have a history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to etanercept or to any of the excipient
  • Have either active or latent TB or who have a history of TB
  • Have clinically significant active infection within 4 weeks before the first IP administration
  • Have had a history of serious infection
  • Have previously been exposed to etanercept, if known
  • Have previously been exposed to a biological agent or immunosuppressive agent within 120 days prior to the first IP administration
  • Have a history of invasive systemic fungal infections or other opportunistic infections judged as relevant by the Investigator

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193203

PRA Health Sciences
Groningen, Netherlands

Samsung Bioepis Co., Ltd.

Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03193203     History of Changes
Other Study ID Numbers: SB4-G12-NHV
2016-004993-16 ( EudraCT Number )
Study First Received: June 19, 2017
Last Updated: June 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on June 20, 2017