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

NCT04617691 | Completed Phase 1

• 2 other identifiers: CR108895CNTO1959EDI1001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Tremfya

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 85

• Percentage of Participants with Serious Adverse Events (SAEs)

  Up to Day 85

• Percentage of Participants with Clinically Significant Changes in Vital Signs

  Up to Day 85

• Percentage of Participants with Clinically Significant Changes in Physical Examinations

  Up to Day 85

• Percentage of Participants with Clinically Significant Changes in Laboratory Safety Tests

  Up to Day 85

Study Arms (2)

Group 1: Guselkumab PFS-U

EXPERIMENTAL

Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution.

Drug: Guselkumab

Group 2: Guselkumab FVP

EXPERIMENTAL

Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution.

Drug: Guselkumab

Interventions

Guselkumab DRUG

Guselkumab will be administered as IV solution derived from FVP or PFS-U.

Group 1: Guselkumab PFS-U; Group 2: Guselkumab FVP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

MeSH Terms

Interventions

guselkumab

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 5, 2020
• Study Start: November 30, 2020
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)