Status:
COMPLETED
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04816513
Start Date
April 14 2021
End Date
January 26 2022
Last Update
April 27 2025
Active Locations (3)
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1
Celerion
Tempe, Arizona, United States, 85283
2
Celerion
Lincoln, Nebraska, United States, 68502
3
PRA Health Sciences
Salt Lake City, Utah, United States, 84124