A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants

An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of the Intravenous Formulation of Guselkumab Using Prefilled Syringes Assembled in an UltraSafe Plus Passive Needle Guard and Intravenous Formulation of Guselkumab Using Final Vialed Product in Healthy Participants

The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • CRS Clinical Research Services Berlin GMBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be healthy on the basis of physical examination, medical history, vital signs and electrocardiogram (ECG) performed at screening. 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
• Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. 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
• Must be a non-user or 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
• Participant is considered eligible according to the following tuberculosis (TB) screening criteria: (a) have no history of latent or active TB before screening; (b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; (c) have had no recent close contact with a person with active TB; (d) have a negative QuantiFERON-TB test result within 28 days prior to the administration 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, neurological 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
• Received any systemic immunosuppressant agent (other than a short course of corticosteroids for minor inflammatory conditions) within 6 months before and during screening and administration of study intervention
• Has a positive urine drug or 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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Guselkumab PFS-U; Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution.	Drug: Guselkumab; Guselkumab will be administered as IV solution derived from FVP or PFS-U.
Experimental: Group 2: Guselkumab FVP; Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution.	Drug: Guselkumab; Guselkumab will be administered as IV solution derived from FVP or PFS-U.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Serum Concentration (Cmax)	Cmax is defined as maximum observed serum concentration.	Up to Day 85
Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity Based on Extrapolation of The Terminal Phase (AUC[0-infinity])	AUC(0-infinity) is defined as area under the serum concentration vs time curve from time 0 to infinity based on extrapolation of the terminal phase.	Up to Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Day 85
Percentage of Participants with Serious Adverse Events (SAEs)	A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Up to Day 85
Percentage of Participants with Clinically Significant Changes in Vital Signs	Percentage of participants with clinically significant changes in vital signs (including temperature (oral), pulse/heart rate, respiratory rate, and blood pressure) will be reported.	Up to Day 85
Percentage of Participants with Clinically Significant Changes in Physical Examinations	Percentage of participants with clinically significant changes in physical examinations (including general appearance, respiratory, cardiovascular, assessment of the skin at or around the intravenous [IV] administration area) will be reported.	Up to Day 85
Percentage of Participants with Clinically Significant Changes in Laboratory Safety Tests	Percentage of participants with clinically significant changes in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.	Up to Day 85
Percentage of Participants with Antibodies to Guselkumab	Percentage of participants with 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): November 30, 2020
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Tremfya
• Other Study ID Numbers: CR108895; CNTO1959EDI1001 (Other Identifier: Janssen Research & Development, LLC)

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No