A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants
A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab
1 other identifier
interventional
60
1 country
2
Brief Summary
The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2026
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedStudy Start
First participant enrolled
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
July 1, 2026
June 1, 2026
7 months
March 9, 2026
June 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately 155 Days
Maximum Observed Serum Concentration (Cmax) of Risankizumab
Cmax of Risankizumab.
Up to Approximately 155 Days
Time to Cmax (Tmax) of Risankizumab
Tmax of Risankizumab.
Up to Approximately 155 Days
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
AUCt of Risankizumab.
Up to Approximately 155 Days
Study Arms (2)
Risankizumab Dose A
EXPERIMENTALParticipants will receive Dose A of risankizumab via intravenous (IV) infusion.
Risankizumab Dose B
EXPERIMENTALParticipants will receive Dose B of risankizumab via subcutaneous (SC) injection.
Interventions
Eligibility Criteria
You may qualify if:
- Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
You may not qualify if:
- Exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
- Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (2)
CenExel ACT- Anaheim Clinical Trials /ID# 281821
Anaheim, California, 92801, United States
Cpmi /Id# 281783
Miami, Florida, 33172, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2026
First Posted
March 12, 2026
Study Start
June 4, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share