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NCT05567029 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
A Phase 1 study of Healthy Volunteers, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 198
- Enrollment target
- 5
- Study locations
NCT05567029: Completed Phase 1 study of Healthy Volunteers, sponsored by AbbVie.
NCT05567029 is a Phase 1 study of Healthy Volunteers that has completed, run by AbbVie. The registered enrollment target is 198 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (59% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05567029, a Phase 1 study of Healthy Volunteers, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 198 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world. All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations. There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
Primary Outcome
Maximum Observed Plasma Concentration (Cmax)
Conditions Studied
Interventions
- DRUG Risankizumab Dose A
- DRUG Risankizumab Dose B
Study Locations (5)
California
- Anaheim Clinical Trials LLC /ID# 250098 - Anaheim
Florida
- Clinical Pharmacology of Miami /ID# 250099 - Miami
Illinois
- Acpru /Id# 249681 - Grayslake
Missouri
- Bio-Kinetic Clinical Applications, LLC /ID# 250181 - Springfield
Texas
- PPD Clinical Research Unit - Austin /ID# 250672 - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2022-09-28 |
| Est. Completion | 2023-04-20 |
| Phase | Phase 1 |
What the finished NCT05567029 record still lists
NCT05567029 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Risankizumab Dose A is the first listed.
NCT05567029 lists 5 locations in 5 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT05567029 about?
NCT05567029 is a clinical study titled "Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.". This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the ...
What is the current status of trial NCT05567029?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 2022-09-28. Estimated completion is 2023-04-20.
What conditions does trial NCT05567029 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05567029?
The interventions under investigation include: Risankizumab Dose A (DRUG), Risankizumab Dose B (DRUG).
Who is sponsoring clinical trial NCT05567029?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05567029 being conducted?
This trial has 5 study locations across California, Florida, Illinois, Missouri, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05567029's enrollment target sits among peer trials
198 49th of 283 higher than 235 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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