Clinical trial NCT04816513: A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
timeFrame: Up to Day 85
measure: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinite])
timeFrame: Up to Day 85
Secondary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 85
measure: Number of Participants with AEs Related to the Injection or at the Injection Site
timeFrame: Up to Day 85
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to Day 85
measure: Number of Participants with Abnormalities in Physical Examinations (PE)
timeFrame: Up to Day 85 (for full PE) and up to Day 57 (for brief PE)
measure: Number of Participants with Abnormalities in Laboratory Tests
timeFrame: Up to Day 85
measure: Number of Participants with Antibodies to Ustekinumab
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: