A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.

Key facts

Study ID

NCT04816513

Run by

Janssen Research & Development, LLC

People needed

300

Starts

2021-04-14

Expected to finish

2022-01-26

Last updated by the study team

2025-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be a non-user or a light user of tobacco products (not smoke more than 10 cigarettes or equivalent a day for at least 6 months prior to screening), including all nicotine use, example, cigarettes (including e-cigarettes or the equivalent of e-cigarettes), cigars, chewing tobacco, patch, gum
• Body weight within the range of 50.0 kilograms (kg) to 90.0 kg, inclusive and body mass index within the range of 18 kilograms per meter square (kg/m\^2) to 30 kg/m\^2 (inclusive)
• A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
• A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 12 weeks after receiving the last dose of study intervention

You may not qualify if…

• 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 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 previously received ustekinumab
• Received an investigational intervention (including investigational vaccines or devices) or used an invasive investigational device within 30 days or 5 half lives before screening or is currently enrolled in an investigational study
• Has a current chronic infection, prior history of recurrent infection, or an active infection

Where it is running

• Celerion — Tempe, Arizona, United States
• Celerion — Lincoln, Nebraska, United States
• PRA Health Sciences — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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