Clinical trial NCT06937619: A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants
Official title: A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Risankizumab
ABBV-066
SKYRIZI
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-04-22
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight greater than 40 kg and less than 100 kg at screening.
* 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

Exclusion Criteria:

* Previous 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 participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Time to Cmax (Tmax) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Terminal Phase Elimination Half-life (t1/2) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
timeFrame: Up to approximately 140 days
measure: Number of Anti-drug antibody (ADA) Titers
timeFrame: Up to approximately 140 days
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 140 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CenExel ACT- Anaheim Clinical Trials /ID# 274805
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research CNS /ID# 275212
state: California
city: Miami
country: United States
facility: Cpmi /Id# 274464
state: Florida
city: Grayslake
country: United States
facility: Acpru /Id# 271954
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: