A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector
| Registry | NCT06937619 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, basic science |
| Enrollment | 263 (Actual) |
| Sponsor | AbbVie (Industry) |
| Conditions | Healthy Volunteer |
| Interventions | Risankizumab (Drug) |
| Dates | start 2025-04-21, primary completion 2025-11-10, completion 2025-11-10, first posted 2025-04-22, last updated 2025-11-17 |
| Locations | 4 sites in United States |
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This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Risankizumab Arm A | Experimental | Drug: Risankizumab | Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1. |
| Risankizumab Arm B | Experimental | Drug: Risankizumab | Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1. |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 274805 | Anaheim, California | United States | |
| Collaborative Neuroscience Research CNS /ID# 275212 | Los Alamitos, California | United States | |
| Cpmi /Id# 274464 | Miami, Florida | United States | |
| Acpru /Id# 271954 | Grayslake, Illinois | United States |