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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-09

Study Completion Date

2013-10-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Guselkumab (lyophilized formulation)

Intervention Type DRUG

Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.

Group 2

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

Group Type EXPERIMENTAL

Guselkumab (liquid formulation with PFS-U)

Intervention Type DRUG

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.

Group 3

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

Group Type EXPERIMENTAL

Guselkumab (liquid formulation with PFS FID)

Intervention Type DRUG

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.

Group 4

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

Group Type EXPERIMENTAL

Guselkumab (liquid formulation)

Intervention Type DRUG

Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.

Interventions

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Guselkumab (lyophilized formulation)

Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.

Intervention Type DRUG

Guselkumab (liquid formulation with PFS-U)

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.

Intervention Type DRUG

Guselkumab (liquid formulation with PFS FID)

Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.

Intervention Type DRUG

Guselkumab (liquid formulation)

Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.

Intervention Type DRUG

Other Intervention Names

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CNTO1959 CNTO1959 CNTO1959 CNTO1959

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes