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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2021-12-07

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Reference Device: Guselkumab

Participants will receive subcutaneous (SC) injections of guselkumab in reference device.

Group Type EXPERIMENTAL

Guselkumab

Intervention Type DRUG

Guselkumab will be administered subcutaneously.

Test Device 1: Guselkumab

Participants will receive SC injections of guselkumab in test device 1.

Group Type EXPERIMENTAL

Guselkumab

Intervention Type DRUG

Guselkumab will be administered subcutaneously.

Test Device 2: Guselkumab

Participants will receive SC injections of guselkumab in test device 2.

Group Type EXPERIMENTAL

Guselkumab

Intervention Type DRUG

Guselkumab will be administered subcutaneously.

Interventions

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Guselkumab

Guselkumab will be administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

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CNTO 1959

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes