> 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-two-82886c6c-1110-4b70-b087-426c107903c8 > Record changed: 2026-10-13 # A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants NCT06571266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) Participants 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) Start date 2024-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Title and summary **Summary** This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Short title** A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Official title** A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Dates **Completion date** 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **First posted** 2024-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Registry last updated** 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Primary completion date** 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Start date** 2024-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Size and sites **Actual participants** 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Participants** 231 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Identifiers **Registry ID** NCT06571266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **ClinicalTrials.gov ID** NCT06571266 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AEs) Timeframe: Up to day 140 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. 2. Maximum Observed Serum Concentration (Cmax) of Risankizumab Timeframe: Up to Day 140 Cmax will be assessed of Risankizumab 3. Time to Cmax (Tmax) of Risankizumab Timeframe: Up to Day 140 Tmax will be assessed of Risankizumab 4. Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab Timeframe: Up to Day 140 Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab 5. Terminal Phase Elimination Half-life (t1/2) of Risankizumab Timeframe: Up to Day 140 Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab 6. Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) Timeframe: Up to Day 140 AUC0-t will be assessed 7. AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab Timeframe: Up to Day 140 AUC0-inf will be assessed of Risankizumab 8. Number of Anti-drug antibody (ADA) Titers Timeframe: Up to Day 140 Incidence and concentration of anti-drug antibodies Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria - Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement - Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement. - 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 - Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening. - Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study. - History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## Sites - Cenexel Act /ID# 270310Anaheim, United States - Collaborative Neuroscience Research CNS /ID# 270286Los Alamitos, United States - Acpru /Id# 270152Grayslake, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06571266) ## 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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