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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04147338

2020-003725-32 (EudraCT Number)

CR108698

CNTO1959CRD1003 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 440 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 3 patient groups

Reference Device: Guselkumab

Experimental group

Description:

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

Treatment:

Drug: Guselkumab

Test Device 1: Guselkumab

Experimental group

Description:

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

Treatment:

Drug: Guselkumab

Test Device 2: Guselkumab

Experimental group

Description:

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

Treatment:

Drug: Guselkumab