Clinical trial NCT04617691: A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Tremfya
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 140
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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Up to Day 85
measure: Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity Based on Extrapolation of The Terminal Phase (AUC[0-infinity])
timeFrame: Up to Day 85
Secondary outcomes:
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 85
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 85
measure: Percentage of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Day 85
measure: Percentage of Participants with Clinically Significant Changes in Physical Examinations
timeFrame: Up to Day 85
measure: Percentage of Participants with Clinically Significant Changes in Laboratory Safety Tests
timeFrame: Up to Day 85
measure: Percentage of Participants with Antibodies to Guselkumab
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: