A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
- Registration Number
- NCT06571266
- Lead Sponsor
- AbbVie
- Brief Summary
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 231
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risankizumab Formulation 1 Risankizumab Participants will receive a single dose of Risankizumab formulation 1 on day 1. Risankizumab Formulation 3 Risankizumab Participants will receive a single dose of Risankizumab formulation 3 on day 1. Risankizumab Formulation 2 Risankizumab Participants will receive a single dose of Risankizumab formulation 2 on day 1.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) 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.
Maximum Observed Serum Concentration (Cmax) of Risankizumab Up to Day 140 Cmax will be assessed of Risankizumab
Time to Cmax (Tmax) of Risankizumab Up to Day 140 Tmax will be assessed of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab Up to Day 140 Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab
Terminal Phase Elimination Half-life (t1/2) of Risankizumab Up to Day 140 Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) Up to Day 140 AUC0-t will be assessed
AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab Up to Day 140 AUC0-inf will be assessed of Risankizumab
Number of Anti-drug antibody (ADA) Titers Up to Day 140 Incidence and concentration of anti-drug antibodies
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Cenexel Act /ID# 270310
🇺🇸Anaheim, California, United States
Collaborative Neuroscience Research CNS /ID# 270286
🇺🇸Los Alamitos, California, United States
Acpru /Id# 270152
🇺🇸Grayslake, Illinois, United States