Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02326233
• Date of registration: 22/12/2014
• Prospective Registration: Yes
• Primary sponsor: Samsung Bioepis Co., Ltd.
• Public title: Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
• Scientific title: A Randomised, Open-labelled, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of the Pre-filled Pen and PFS of SB5 in Healthy Subjects
• Date of first enrolment: June 2015
• Target sample size: 190
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02326233
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, New Zealand

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy subjects

- Have a body mass index between 20.0 to 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
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 subject's last visit

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: Pen of SB5

Biological: PFS of SB5

Primary Outcome(s)

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) [Time Frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose]

Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) [Time Frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose]

Maximum Serum Concentration (Cmax) [Time Frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose]

Secondary Outcome(s)

Time to Reach Cmax (Tmax) [Time Frame: 0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose]

Secondary ID(s)

2014-005178-12

SB5-G12-NHV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02326233