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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816513
• Other study ID #: CR108948
• Secondary ID: CNTO1275EDI1001
• Status: Completed
• Phase: Phase 1
• Start date: April 14, 2021
• Est. completion date: January 26, 2022

Study information

• Verified date: February 2022
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 26, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Ustekinumab
Ustekinumab will be administered as SC injection.

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska
United States	PRA Health Sciences	Salt Lake City	Utah
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentrations (Cmax) of Ustekinumab	Cmax is maximum observed serum concentration of ustekinumab.	Up to Day 85
Primary	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	Number of Participants with Treatment-emergent Adverse Events (TEAEs)	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.	Up to Day 85
Secondary	Number of Participants with AEs Related to the Injection or at the Injection Site	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.	Up to Day 85
Secondary	Number of Participants with Abnormalities in Vital Signs	Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, respiratory rate, and blood pressure [systolic and diastolic]) will be reported.	Up to Day 85
Secondary	Number of Participants with Abnormalities in Physical Examinations (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.	Up to Day 85 (for full PE) and up to Day 57 (for brief PE)
Secondary	Number of Participants with Abnormalities in Laboratory Tests	Number of participants with abnormalities in laboratory tests (serum chemistry and hematology and urinalysis) will be reported.	Up to Day 85
Secondary	Number of Participants with Antibodies to Ustekinumab	Number of participants with antibodies to ustekinumab will be reported.	Up to Day 85