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NCT02996019 · ClinicalTrials.gov registry record · Phase 1
A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 180
- Enrollment target
NCT02996019: Completed Phase 1 study, sponsored by Genentech.
NCT02996019 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 180 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (200% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996019, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 180 participants
- Enrollment target
Study Summary
This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric mean ratio (GMR) and variability of the maximum observed concentration (Cmax) and area under the concentration-time curve (AUC) to confirm or determine the sample size for the pivotal cohort (Part 2). The pivotal cohort will demonstrate exposure comparability of Cmax, AUC from Hour 0 to the last measurable concentration (AUClast), and AUC from Hour 0 to extrapolated infinite time (AUC0-inf), values for a single dose of etrolizumab administered subcutaneously either by the AI or the PFS-NSD.
Interventions
- DRUG Etrolizumab
- DEVICE Auto-Injector (AI)
- DEVICE Prefilled Syringe With Needle Safety Device (PFS-NSD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2016-12-07 |
| Est. Completion | 2018-04-09 |
| Phase | Phase 1 |
What the finished NCT02996019 record still lists
NCT02996019 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (200% higher).
The record links to 0 conditions, and to 3 interventions - of which Etrolizumab is the first listed.
NCT02996019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02996019 about?
NCT02996019 is a clinical study titled "A Study to Compare Pharmacokinetics (PK) of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD) or an Auto-injector (AI)". This is a randomized, 2-part, 2-arm, open-label, parallel-group, multi-center study to compare the PK of etrolizumab administered subcutaneously by an AI (test device) or a PFS-NSD (reference device) in healthy participants. The study will comprise a pilot cohort (Part 1) to estimate the geometric m...
What is the current status of trial NCT02996019?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2016-12-07. Estimated completion is 2018-04-09.
What interventions are being tested in trial NCT02996019?
The interventions under investigation include: Etrolizumab (DRUG), Auto-Injector (AI) (DEVICE), Prefilled Syringe With Needle Safety Device (PFS-NSD) (DEVICE).
Who is sponsoring clinical trial NCT02996019?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02996019's enrollment target sits among peer trials
180 299th of 2000 higher than 1,690 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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