A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants
- Summary
- This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe
- Short title
- A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants
- Official title
- A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Subcutaneous Administration With On-Body Injector Relative to Prefilled Syringe
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-01-15
- First posted
- 2025-06-05
- Registry last updated
- 2026-01-27
- Primary completion date
- 2026-01-15
- Start date
- 2025-06-12
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07007091
- ClinicalTrials.gov ID
- NCT07007091
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
Maximum Observed Plasma Concentration (Cmax) of Risankizumab
Timeframe: Up to Approximately 113 days
Maximum observed plasma concentration (Cmax) of Risankizumab
Time to Cmax (Tmax) of Risankizumab
Timeframe: Up to Approximately 113 days
Tmax of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
Timeframe: Up to Approximately 113 days
Apparent terminal phase elimination rate constant (β) of Risankizumab
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
Timeframe: Up to Approximately 113 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
Timeframe: Up to Approximately 113 days
AUCt of Risankizumab
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
Timeframe: Up to Approximately 113 days
AUCinf of Risankizumab
Number of Anti-drug antibodies (ADA)
Timeframe: Up to Approximately 113 days
Incidence of anti-drug antibodies
Number of Participants Experiencing Adverse Events
Timeframe: Up to Approximately 113 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
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight between 40 kg and 100 kg, inclusive, at the time of 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 (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
- Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.
- Cpmi /Id# 276490Miami, United States
- Acpru /Id# 276043Grayslake, United States
- Ppd - Las Vegas Research Unit /ID# 276565Las Vegas, United States
- PPD Phase I Clinic /ID# 276525Austin, United States