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NCT02079545 · ClinicalTrials.gov registry record · Phase 1
Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 144
- Enrollment target
NCT02079545 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 144 participants.
The verdict
NCT02079545, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 144 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passive™ Delivery system (PFS-U) with the SmartJect™ Autoinjector (PFS-AI) in healthy male participants.
Interventions
- DRUG Sirukumab (IV infusion)
- DRUG Sirukumab (SC injection with PFS-U)
- DRUG Sirukumab (SC injection with PFS-AI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02079545
The ClinicalTrials.gov registry entry for NCT02079545 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sirukumab (IV infusion) is the first listed.
NCT02079545 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02079545 about?
NCT02079545 is a clinical study titled "Bioavailability and Pharmacokinetics Study of Sirukumab in Healthy Male Participants". The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe ...
What is the current status of trial NCT02079545?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2014-03. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02079545?
The interventions under investigation include: Sirukumab (IV infusion) (DRUG), Sirukumab (SC injection with PFS-U) (DRUG), Sirukumab (SC injection with PFS-AI) (DRUG).
Who is sponsoring clinical trial NCT02079545?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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