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NCT02156375 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT02156375: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02156375 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02156375, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.
Primary Outcome
The Cmax is the maximum observed plasma concentration of study drug.
Interventions
- DRUG Ustekinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2014-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02156375 record still lists
NCT02156375 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (133% higher).
The record links to 0 conditions, and to 1 intervention - of which Ustekinumab is the first listed.
NCT02156375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02156375 about?
NCT02156375 is a clinical study titled "A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations". The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels) comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL) liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6 milligram per kilogram (mg/kg) ustek...
What is the current status of trial NCT02156375?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2014-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02156375?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT02156375?
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 NCT02156375's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 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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