A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants
- Registration Number
- NCT06937619
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 252
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Risankizumab Arm A Risankizumab Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1. Risankizumab Arm B Risankizumab Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Risankizumab Up to approximately 140 days Maximum observed plasma concentration (Cmax) of Risankizumab
Time to Cmax (Tmax) of Risankizumab Up to approximately 140 days Tmax of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab Up to approximately 140 days Apparent terminal phase elimination rate constant (β) of Risankizumab
Terminal Phase Elimination Half-life (t1/2) of Risankizumab Up to approximately 140 days Terminal phase elimination half-life (t1/2) of Risankizumab
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab Up to approximately 140 days AUCt of Risankizumab
Number of Anti-drug antibody (ADA) Titers Up to approximately 140 days Incidence and concentration of anti-drug antibodies
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab Up to approximately 140 days AUCinf of Risankizumab
Number of Participants Experiencing Adverse Events 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Collaborative Neuroscience Research CNS /ID# 275212
🇺🇸Los Alamitos, California, United States
CenExel ACT- Anaheim Clinical Trials /ID# 274805
🇺🇸Anaheim, California, United States
Cpmi /Id# 274464
🇺🇸Miami, Florida, United States