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

NCT04816513 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR108948CNTO1275EDI1001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Serum Concentrations (Cmax) of Ustekinumab

  Cmax is maximum observed serum concentration of ustekinumab.

  Up to Day 85

• Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinite])

  AUC (0-Infinite) defined as area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase will be evaluated.

  Up to Day 85

Secondary Outcomes (6)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 85

• Number of Participants with AEs Related to the Injection or at the Injection Site

  Up to Day 85

• Number of Participants with Abnormalities in Vital Signs

  Up to Day 85

• Number of Participants with Abnormalities in Physical Examinations (PE)

  Up to Day 85 (for full PE) and up to Day 57 (for brief PE)

• Number of Participants with Abnormalities in Laboratory Tests

  Up to Day 85

Study Arms (2)

Ustekinumab (Using Reference Device)

ACTIVE COMPARATOR

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

Drug: Ustekinumab

Ustekinumab (Using Test Device)

EXPERIMENTAL

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

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

Ustekinumab will be administered as SC injection.

Also known as: CNTO1275, STELARA

Ustekinumab (Using Reference Device); Ustekinumab (Using Test Device)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Celerion

Tempe, Arizona, 85283, United States

Location

Celerion

Lincoln, Nebraska, 68502, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 25, 2021
• Study Start: April 14, 2021
• Primary Completion: January 7, 2022
• Study Completion: January 26, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)