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

• Sponsor: Samsung Bioepis Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03193203
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 11.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Etanercept	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• 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
• Actual Study Start Date: Mar 24, 2017
• Actual Primary Completion Date: Aug 7, 2017
• Actual Study Completion Date: Aug 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 SB4 (etanercept) 50 mg/mL PFS and AI	Drug: Etanercept; 50 mg/mL PFS and AI
Experimental: Sequence 2 SB4 (etanercept) 50 mg/mL AI and PFS	Drug: Etanercept; 50 mg/mL PFS and AI

Outcome Measures

Primary Outcome Measures

1. AUCinf ACUinf [56 days]

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

2. AUClast [56 days]

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

3. Cmax [56 days]

   Maximum serum concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Groningen		Netherlands

Sponsors and Collaborators

• Samsung Bioepis Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Bioepis Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03193203
• Other Study ID Numbers: SB4-G12-NHV; 2016-004993-16
• First Posted: Jun 20, 2017
• Last Update Posted: Sep 28, 2017
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Etanercept

Study Results

No Results Posted as of Sep 28, 2017