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OpenTrials
Completed

NCT Number: NCT04816513

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

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ustekinumab

Drug

Ustekinumab will be administered as SC injection.

Other names: CNTO1275, STELARA

Primary outcomes

  1. Maximum Observed Serum Concentrations (Cmax) of Ustekinumab

    Time frame: Up to Day 85

    Cmax is maximum observed serum concentration of ustekinumab.

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

    Time frame: Up to Day 85

    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.

Secondary outcomes

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

    Time frame: Up to Day 85

    An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.

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

    Time frame: Up to Day 85

    Number of participants with AEs related to injection or at the injection site will be reported. Symptoms such as erythema, induration and pruritis that in the opinion of the investigator may be associated with the administration, will be captured as an AE (example, injection-site erythema, injection-site induration, injection-site pruritis or injection-site pain.

  3. Number of Participants with Abnormalities in Vital Signs

    Time frame: Up to Day 85

    Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, respiratory rate, and blood pressure [systolic and diastolic]) will be reported.

  4. Number of Participants with Abnormalities in Physical Examinations (PE)

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

    Number of participants with abnormalities in physical examinations (full and brief) will be reported. Full physical examinations will include a review of the following body systems: general appearance; thorough skin and oral mucosa evaluation; eyes, ears, nose, and throat; cardiovascular; respiratory; abdomen; peripheral pulsation; lymph nodes; neurologic (including examination for muscle strength and sensory exam); musculoskeletal; head, neck, and thyroid. A brief physical examination includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area.

  5. Number of Participants with Abnormalities in Laboratory Tests

    Time frame: Up to Day 85

    Number of participants with abnormalities in laboratory tests (serum chemistry and hematology and urinalysis) will be reported.

  6. Number of Participants with Antibodies to Ustekinumab

    Time frame: Up to Day 85

    Number of participants with antibodies to ustekinumab will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of Ustekinumab Following a Single Subcutaneous Administration by Two Different Injection Devices in Healthy Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2021
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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