A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Guselkumab

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • CRS Clinical Research Services
• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Reference Device: Guselkumab; Participants will receive subcutaneous (SC) injections of guselkumab in reference device.	Drug: Guselkumab; Guselkumab will be administered subcutaneously.; Other Names: CNTO 1959
EXPERIMENTAL: Test Device 1: Guselkumab; Participants will receive SC injections of guselkumab in test device 1.	Drug: Guselkumab; Guselkumab will be administered subcutaneously.; Other Names: CNTO 1959
EXPERIMENTAL: Test Device 2: Guselkumab; Participants will receive SC injections of guselkumab in test device 2.	Drug: Guselkumab; Guselkumab will be administered subcutaneously.; Other Names: CNTO 1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Serum Concentration (Cmax)	Cmax is the maximum observed serum concentration.	Up to Day 85
Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])	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.	Up to Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	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.	Up to 113 days
Number of Participants with Clinically Significant Vital Signs Abnormalities	Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported.	Up to 113 days
Number of Participants with Clinically Significant Physical Examination Abnormalities	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.	Up to 113 days
Number of Participants with Clinically Significant Laboratory Abnormalities	Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.	Up to 113 days
Number of Participants with Anti-Guselkumab Antibodies	Number of participants with anti-drug antibodies to guselkumab will be reported.	Up to Day 85

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 30, 2019
• Primary Completion (ACTUAL): September 13, 2021
• Study Completion (ACTUAL): December 7, 2021

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (ACTUAL): November 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CR108698; CNTO1959CRD1003 (OTHER: Janssen Research & Development, LLC); 2020-003725-32 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No