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NCT02629744 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02629744: Completed Phase 1 study, sponsored by Genentech.
NCT02629744 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02629744, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study is a multi-center, single-arm, open-label study in healthy participants to assess the pain, tolerability, injection leakage, safety, and usability of a single self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive "needle-experience" training using a needle and syringe on Days -7 and -5, and health care professionals (HCPs) will then assess the participant's suitability to self-inject with a prefilled auto-injector (AI). The remainder of participants will be "needle naïve" and will not have previously self-injected. Eligible" needle experienced" and" needle naive" participants will attend an AI training visit at the study site on Day -3 (three days prior to etrolizumab dosing on Day 1). Following training and simulated injections by the participant the HCP will determine if the participant is suitable to proceed to actual etrolizumab dosing. All eligible study participants will self administer a single dose of etrolizumab (by AI) on Day 1 and will be followed up to Day 85 following dosing. Pain, tolerability, safety and usuability will be assessed.
Interventions
- DRUG Etrolizumab
- DEVICE Prefilled Auto-injector (Rotaject)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT02629744 record still lists
NCT02629744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Etrolizumab is the first listed.
NCT02629744 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02629744 about?
NCT02629744 is a clinical study titled "A Study to Evaluate Pain, Tolerability, Safety, and Usability of a Single Self-administered Etrolizumab by Auto-injector in Healthy Participants". This study is a multi-center, single-arm, open-label study in healthy participants to assess the pain, tolerability, injection leakage, safety, and usability of a single self-administered subcutaneous (SC) dose of etrolizumab. Some participants will receive "needle-experience" training using a needl...
What is the current status of trial NCT02629744?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02629744?
The interventions under investigation include: Etrolizumab (DRUG), Prefilled Auto-injector (Rotaject) (DEVICE).
Who is sponsoring clinical trial NCT02629744?
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 NCT02629744's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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