A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Guselkumab (liquid formulation with PFS FID); Drug: Guselkumab (liquid formulation with PFS-U); Drug: Guselkumab (lyophilized formulation); Drug: Guselkumab (liquid formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01866007

CR100969

CNTO1959NAP1001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.

Full description

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous [SC] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.

Enrollment: 141 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participant with no clinically significant abnormalities
• Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants
• Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2
• Agrees to protocol-defined use of effective contraception

Exclusion criteria

• Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease
• Currently have any known malignancy or have a history of malignancy
• Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments
• Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 4 patient groups

Group 1

Experimental group

Description:

40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation.

Treatment:

Drug: Guselkumab (lyophilized formulation)

Group 2

Experimental group

Description:

40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U).

Treatment:

Drug: Guselkumab (liquid formulation with PFS-U)

Group 3

Experimental group

Description:

40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID).

Treatment:

Drug: Guselkumab (liquid formulation with PFS FID)

Group 4

Experimental group

Description:

20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation.

Treatment:

Drug: Guselkumab (liquid formulation)