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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Guselkumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04617691

CR108895

CNTO1959EDI1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Group 1: Guselkumab PFS-U

Experimental group

Description:

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

Treatment:

Drug: Guselkumab

Group 2: Guselkumab FVP

Experimental group

Description:

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

Treatment:

Drug: Guselkumab