A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
- Registration Number
- NCT04147338
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive
- Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention
- 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 (GI) 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 a current chronic infection, prior history of recurrent infection, or an active infection
- Has previously received guselkumab
- Has a positive urine drug and alcohol screen during screening or at admission (Day -1)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Device 2: Guselkumab Guselkumab Participants will receive SC injections of guselkumab in test device 2. Reference Device: Guselkumab Guselkumab Participants will receive subcutaneous (SC) injections of guselkumab in reference device. Test Device 1: Guselkumab Guselkumab Participants will receive SC injections of guselkumab in test device 1.
- Primary Outcome Measures
Name Time Method Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity]) Up to Day 85 AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Maximum Observed Serum Concentration (Cmax) Up to Day 85 Cmax is the maximum observed serum concentration.
- Secondary Outcome Measures
Name Time Method Number of Participants with Clinically Significant Physical Examination Abnormalities Up to 113 days Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported.
Number of Participants with Clinically Significant Laboratory Abnormalities Up to 113 days Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.
Number of Participants with Anti-Guselkumab Antibodies Up to Day 85 Number of participants with anti-drug antibodies to guselkumab will be reported.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Up to 113 days An adverse event 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 AEs which will occur up to 113 days that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants with Clinically Significant Vital Signs Abnormalities Up to 113 days Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported.
Trial Locations
- Locations (2)
CRS Clinical Research Services
🇩🇪Mannheim, Germany
Celerion
🇺🇸Tempe, Arizona, United States