A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection 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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2022-01-26

Brief Summary

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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.

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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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Ustekinumab (Using Reference Device)

Participants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1.

Group Type ACTIVE_COMPARATOR

Ustekinumab

Intervention Type DRUG

Ustekinumab will be administered as SC injection.

Ustekinumab (Using Test Device)

Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1.

Group Type EXPERIMENTAL

Ustekinumab

Intervention Type DRUG

Ustekinumab will be administered as SC injection.

Interventions

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Ustekinumab

Ustekinumab will be administered as SC injection.

Intervention Type DRUG

Other Intervention Names

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CNTO1275, STELARA

Eligibility Criteria

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Inclusion Criteria

* 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

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes