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NCT02678988 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers
A Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 189
- Enrollment target
- 3
- Study locations
NCT02678988 is a Phase 1 study of Healthy Volunteer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 189 participants, roughly in line with the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target. The trial reports 3 study locations across 3 states.
The verdict
NCT02678988, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 189 participants
- Enrollment target
- 3
- Study locations
Study Summary
The study consists of an eligibility screening period, two study periods involving single doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy participants will receive a single subcutaneous (SC) injection of TCZ via a pre-filled syringe-needle safety device (PFS-NSD) and a single injection via an autoinjector (AI). The total duration of the study is up to 16 weeks from screening to follow-up. After screening, eligible participants will be randomly assigned to one of the two possible treatment sequences (Sequence 1: AI-1000 G2 followed by PFS-NSD or Sequence 2: PFS-NSD followed by AI-1000 G2) and assigned to one of three injection sites (1: abdomen, 2: thigh, or 3: upper arm). All participant groups will receive a total of two TCZ administrations each.
Conditions Studied
Interventions
- DRUG Tocilizumab
- DEVICE AI-1000 G2
- DEVICE PFS-NSD
Study Locations (3)
Kansas
- - Lenexa
New Jersey
- - Marlton
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2016-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02678988
The ClinicalTrials.gov registry entry for NCT02678988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 3 interventions - of which Tocilizumab is the first listed.
NCT02678988 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Kansas, New Jersey, Utah.
Frequently Asked Questions
What is clinical trial NCT02678988 about?
NCT02678988 is a clinical study titled "A Study to Evaluate the Bioequivalence of Tocilizumab Following Subcutaneous Administration Via an Autoinjector (AI 1000-G2) Versus a Pre-Filled Syringe in Healthy Volunteers". The study consists of an eligibility screening period, two study periods involving single doses of tocilizumab (TCZ) according to an open-label, randomized, two-period crossover design with an interval of 6 weeks between periods, and a 6 week follow-up period. Healthy participants will receive a sin...
What is the current status of trial NCT02678988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 189 participants. The study started on 2016-02. Estimated completion is 2016-06.
What conditions does trial NCT02678988 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT02678988?
The interventions under investigation include: Tocilizumab (DRUG), AI-1000 G2 (DEVICE), PFS-NSD (DEVICE).
Who is sponsoring clinical trial NCT02678988?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02678988 being conducted?
This trial has 3 study locations across Kansas, New Jersey, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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