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NCT01866007 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
NCT01866007: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT01866007 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 141 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01866007, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
Study 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.
Interventions
- DRUG Guselkumab (lyophilized formulation)
- DRUG Guselkumab (liquid formulation with PFS-U)
- DRUG Guselkumab (liquid formulation with PFS FID)
- DRUG Guselkumab (liquid formulation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2013-05-09 |
| Est. Completion | 2013-10-09 |
| Phase | Phase 1 |
What the finished NCT01866007 record still lists
NCT01866007 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (135% higher).
The record links to 0 conditions, and to 4 interventions - of which Guselkumab (lyophilized formulation) is the first listed.
NCT01866007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01866007 about?
NCT01866007 is a clinical study titled "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 UltraSaf...
What is the current status of trial NCT01866007?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2013-05-09. Estimated completion is 2013-10-09.
What interventions are being tested in trial NCT01866007?
The interventions under investigation include: Guselkumab (lyophilized formulation) (DRUG), Guselkumab (liquid formulation with PFS-U) (DRUG), Guselkumab (liquid formulation with PFS FID) (DRUG), Guselkumab (liquid formulation) (DRUG).
Who is sponsoring clinical trial NCT01866007?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01866007's enrollment target sits among peer trials
141 401st of 2000 higher than 1,599 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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