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Completed

NCT Number: NCT01866007

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tempe, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guselkumab (lyophilized formulation)

Drug

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

Other names: CNTO1959

Guselkumab (liquid formulation with PFS-U)

Drug

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

Other names: CNTO1959

Guselkumab (liquid formulation with PFS FID)

Drug

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

Other names: CNTO1959

Guselkumab (liquid formulation)

Drug

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

Other names: CNTO1959

Primary outcomes

  1. Maximum observed serum concentration (Cmax) of guselkumab

    Time frame: Day 1 through Week 12

  2. Area under the curve (AUC) from time 0 to 70 days of guselkumab

    Time frame: Day 1 through Week 12

Secondary outcomes

  1. Absolute bioavailability of guselkumab

    Time frame: Day 1 through Week 12

    Bioavailability will be evaluated by using formula: AUC from time zero to infinity with extrapolation of the terminal phase of SC injection divided by AUC from time zero to infinity with extrapolation of the terminal phase of IV infusion of guselkumab and multiplied by 100.

  2. Immunogenicity of guselkumab

    Time frame: Day 1 through Week 12

    Plasma levels of antibodies to guselkumab for evaluation of potential immunogenicity.

  3. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO1959) Delivered by 2 Different Devices in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 31, 2013
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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