A Phase 1 interventional study of Risankizumab in Healthy Volunteers, sponsored by AbbVie. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
The objective of this study is to assess the impact of different warm-up times of risankizumab autoinjector (AI) on the participant injection site pain experience in healthy adult volunteers.
AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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- Body mass index (BMI) is >= 18.0 to \<= 30.0 kg/m2.
Exclusion Criteria:
Participants will receive Regimen A (15-minute autoinjector (AI) warm-up time) in Period 1, Regimen B (30-minute AI warm-up time) in Period 2 followed by Regimen C (45-minute AI warm-up time) in Period 3.
Drug: Risankizumab
Participants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3.
Drug: Risankizumab
Participants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3.
Drug: Risankizumab
Subcutaneous autoinjector
Also known as: SKYRIZI
Change in Injection Site Pain Assessed Using Visual Analog Scale
Injection site-related pain assessments will be recorded directly by the participant using a VAS after the injection is complete (within approximately 5 minutes and 1 hour post-dose).
Time frame: Up to approximately 15 days
Percentage of Participants Experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time frame: Up to approximately 155 days
Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ)
SIAQ is an electronic patient-reported outcomes (ePRO) device assessing participant acceptability with scores ranging from 0 (worst experience) to 10 (best experience).
Time frame: Up to approximately 15 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Risankizumab