Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT05567029
- Run by
- AbbVie
- People needed
- 198
- Starts
- 2022-09-28
- Expected to finish
- 2023-04-20
- Last updated by the study team
- 2023-04-28
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
You may not qualify if…
- Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
- Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.
Where it is running
- Anaheim Clinical Trials LLC /ID# 250098 — Anaheim, California, United States
- Clinical Pharmacology of Miami /ID# 250099 — Miami, Florida, United States
- Acpru /Id# 249681 — Grayslake, Illinois, United States
- Bio-Kinetic Clinical Applications, LLC /ID# 250181 — Springfield, Missouri, United States
- PPD Clinical Research Unit - Austin /ID# 250672 — Austin, Texas, United States
Full record on ClinicalTrials.gov
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