A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.

Official Title
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An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Guselkumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention Exclusion Criteria: History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurologic or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence Has a current chronic infection, prior history of recurrent infection, or an active infection Has previously received guselkumab Has a positive urine drug and alcohol screen during screening or at admission (Day -1)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Reference Device: Guselkumab<br>Participants will receive subcutaneous (SC) injections of guselkumab in reference device. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO 1959;|
| Experimental: Test Device 1: Guselkumab<br>Participants will receive SC injections of guselkumab in test device 1. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO 1959;|
| Experimental: Test Device 2: Guselkumab<br>Participants will receive SC injections of guselkumab in test device 2. | Drug: Guselkumab<br>* Guselkumab will be administered subcutaneously.<br>* Other names: CNTO 1959;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) | Cmax is the maximum observed serum concentration. | Up to Day 85 | 
| Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity]) | AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant. | Up to Day 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur up to 113 days that were absent before treatment or that worsened relative to pre-treatment state. | Up to 113 days | 
| Number of Participants with Clinically Significant Vital Signs Abnormalities | Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported. | Up to 113 days | 
| Number of Participants with Clinically Significant Physical Examination Abnormalities | Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported. | Up to 113 days | 
| Number of Participants with Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported. | Up to 113 days | 
| Number of Participants with Anti-Guselkumab Antibodies | Number of participants with anti-drug antibodies to guselkumab will be reported. | Up to Day 85 |