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NCT04816513 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
A Phase 1 study of Healthy, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT04816513 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 300 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (54% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04816513, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
Conditions Studied
Interventions
- DRUG Ustekinumab
Study Locations (3)
Arizona
- Celerion - Tempe
Nebraska
- Celerion - Lincoln
Utah
- PRA Health Sciences - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2022-01-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04816513
The ClinicalTrials.gov registry entry for NCT04816513 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (54% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Ustekinumab is the first listed.
NCT04816513 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Nebraska, Utah.
Frequently Asked Questions
What is clinical trial NCT04816513 about?
NCT04816513 is a clinical study titled "A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants". The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
What is the current status of trial NCT04816513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2021-04-14. Estimated completion is 2022-01-26.
What conditions does trial NCT04816513 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT04816513?
The interventions under investigation include: Ustekinumab (DRUG).
Who is sponsoring clinical trial NCT04816513?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04816513 being conducted?
This trial has 3 study locations across Arizona, Nebraska, 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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