Clinical trial NCT04147338: A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
Official title: An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different 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: 2019-11-01
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.


Eligibility criteria: Inclusion Criteria:

* 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

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 (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)

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Up to Day 85
measure: Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])
timeFrame: Up to Day 85
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 113 days
measure: Number of Participants with Clinically Significant Vital Signs Abnormalities
timeFrame: Up to 113 days
measure: Number of Participants with Clinically Significant Physical Examination Abnormalities
timeFrame: Up to 113 days
measure: Number of Participants with Clinically Significant Laboratory Abnormalities
timeFrame: Up to 113 days
measure: Number of Participants with Anti-Guselkumab Antibodies
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
city: Mannheim
country: Germany
facility: CRS Clinical Research Services
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: