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

NCT02326233 | Completed Phase 1 Results

• 2 other identifiers: SB5-G12-NHV2014-005178-12
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  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 the Last Quantifiable Concentration (AUClast)

  0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose

• Maximum Serum Concentration (Cmax)

  0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose

Secondary Outcomes (1)

• Time to Reach Cmax (Tmax)

  0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose

Study Arms (2)

Pen of SB5

EXPERIMENTAL

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

Biological: Pen of SB5

PFS of SB5

ACTIVE COMPARATOR

PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug)

Biological: PFS of SB5

Interventions

Pen of SB5 BIOLOGICAL

Pen of SB5

PFS of SB5 BIOLOGICAL

PFS of SB5

Eligibility Criteria

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

You may qualify if:

• Healthy subjects
• Have a body mass index between 20.0 to 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 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (2)

Samsung Investigational Site

Antwerp, Belgium

Location

Samsung Investigational Site

Auckland, New Zealand

Location

Related Publications (1)

• Shin D, Lee Y, Jeong D, Ellis-Pegler R. Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects. Drug Des Devel Ther. 2018 Nov 5;12:3799-3805. doi: 10.2147/DDDT.S169082. eCollection 2018.

  PMID: 30464411 DERIVED

Results Point of Contact

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

sbregistry@samsung.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 29, 2014
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2018-12

Locations

BE (1); NZ (1)