A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
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
2 other identifiers
interventional
141
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2013
Typical duration for phase_1 healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2013
CompletedFirst Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2013
CompletedJanuary 27, 2020
January 1, 2020
4 months
May 28, 2013
January 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum observed serum concentration (Cmax) of guselkumab
Day 1 through Week 12
Area under the curve (AUC) from time 0 to 70 days of guselkumab
Day 1 through Week 12
Secondary Outcomes (3)
Absolute bioavailability of guselkumab
Day 1 through Week 12
Immunogenicity of guselkumab
Day 1 through Week 12
Number of participants with adverse events as a measure of safety and tolerability
Up to 12 weeks
Study Arms (4)
Group 1
EXPERIMENTAL40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation.
Group 2
EXPERIMENTAL40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U).
Group 3
EXPERIMENTAL40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID).
Group 4
EXPERIMENTAL20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation.
Interventions
Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.
Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
Lincoln, Nebraska, United States
Unknown Facility
Neptune City, New Jersey, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2013
First Posted
May 31, 2013
Study Start
May 9, 2013
Primary Completion
September 20, 2013
Study Completion
October 9, 2013
Last Updated
January 27, 2020
Record last verified: 2020-01