Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02678988 record still lists
NCT02678988 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 200-participant average among 112 other Healthy Volunteer trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02678988's enrollment target sits among peer trials
189 20th of 112 higher than 93 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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
-
Healthy Volunteer Study
RECRUITING · Phase 1
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
RECRUITING · Phase 1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
RECRUITING · Phase 1
-
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
RECRUITING · Phase 1
-
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02734537 · 189 participants · Phase 2
Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
- NCT05058651 · 189 participants · Phase 2
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
- NCT05673408 · 189 participants
NIBP Validation Study
- NCT05994209 · 189 participants · Phase 1
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia