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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: Pen of SB5
* Biological: PFS of SB5


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pen of SB5<br>Pen of SB5, single-dose of 40 mg via subcutaneous injection (study drug) | Biological: Pen of SB5<br> <br> |
| Active Comparator: PFS of SB5<br>PFS of SB5, single-dose of 40 mg via subcutaneous injection (reference drug) | Biological: PFS of SB5<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |