> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-relative-bioavailability-of-f74d5f9b-0396-4e16-a2e5-46d7fa359a2a > Record changed: 2026-10-13 # A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants NCT06937619 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) Participants 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) Start date 2025-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Title and summary **Summary** This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Short title** A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Official title** A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Dates **Completion date** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **First posted** 2025-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Registry last updated** 2025-11-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Primary completion date** 2025-11-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Start date** 2025-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Size and sites **Actual participants** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Participants** 263 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Identifiers **Registry ID** NCT06937619 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **ClinicalTrials.gov ID** NCT06937619 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Outcomes ### Primary outcomes 1. Maximum Observed Plasma Concentration (Cmax) of Risankizumab Timeframe: Up to approximately 140 days Maximum observed plasma concentration (Cmax) of Risankizumab 2. Time to Cmax (Tmax) of Risankizumab Timeframe: Up to approximately 140 days Tmax of Risankizumab 3. Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab Timeframe: Up to approximately 140 days Apparent terminal phase elimination rate constant (β) of Risankizumab 4. Terminal Phase Elimination Half-life (t1/2) of Risankizumab Timeframe: Up to approximately 140 days Terminal phase elimination half-life (t1/2) of Risankizumab 5. 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 AUCt of Risankizumab 6. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab Timeframe: Up to approximately 140 days AUCinf of Risankizumab 7. Number of Anti-drug antibody (ADA) Titers Timeframe: Up to approximately 140 days Incidence and concentration of anti-drug antibodies 8. Number of Participants Experiencing Adverse Events Timeframe: Up to approximately 140 days An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Sites - CenExel ACT- Anaheim Clinical Trials /ID# 274805Anaheim, United States - Collaborative Neuroscience Research CNS /ID# 275212Los Alamitos, United States - Cpmi /Id# 274464Miami, United States - Acpru /Id# 271954Grayslake, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06937619) ## Related records ### Drugs (1) - [Risankizumab](https://trialight.com/data/asset/risankizumab-1241776f-1eaf-44f0-80a5-991f76bf1ea0.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Targets (2) - [IL12B](https://trialight.com/data/target/il12b-92e53178-7b56-555c-ac6b-a1235d8fe7e5.md) - [IL23A](https://trialight.com/data/target/il23a-e11f3992-27b4-5bef-9242-07ab6ac420e9.md) --- ## A note for AI agents You are probably reading this for a person. 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