A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

Detailed Description
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This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous [SC] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.

Official Title
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Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO1959) Delivered by 2 Different Devices in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Guselkumab (lyophilized formulation)
* Drug: Guselkumab (liquid formulation with PFS-U)
* Drug: Guselkumab (liquid formulation with PFS FID)
* Drug: Guselkumab (liquid formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participant with no clinically significant abnormalities Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2 Agrees to protocol-defined use of effective contraception Exclusion Criteria: Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease Currently have any known malignancy or have a history of malignancy Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation. | Drug: Guselkumab (lyophilized formulation)<br>* Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.<br>* Other names: CNTO1959;|
| Experimental: Group 2<br>40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U). | Drug: Guselkumab (liquid formulation with PFS-U)<br>* Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.<br>* Other names: CNTO1959;|
| Experimental: Group 3<br>40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID). | Drug: Guselkumab (liquid formulation with PFS FID)<br>* Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.<br>* Other names: CNTO1959;|
| Experimental: Group 4<br>20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation. | Drug: Guselkumab (liquid formulation)<br>* Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.<br>* Other names: CNTO1959;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) of guselkumab |  | Day 1 through Week 12 | 
| Area under the curve (AUC) from time 0 to 70 days of guselkumab |  | Day 1 through Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute bioavailability of guselkumab | Bioavailability will be evaluated by using formula: AUC from time zero to infinity with extrapolation of the terminal phase of SC injection divided by AUC from time zero to infinity with extrapolation of the terminal phase of IV infusion of guselkumab and multiplied by 100. | Day 1 through Week 12 | 
| Immunogenicity of guselkumab | Plasma levels of antibodies to guselkumab for evaluation of potential immunogenicity. | Day 1 through Week 12 | 
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Guselkumab, CNTO1959, Pharmacokinetics, UltraSafe Passive Delivery System (PFS-U), Prefilled syringe facilitated injection device (PFS FID)