A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
- Summary
- This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
- Short title
- A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-04-16
- First posted
- 2024-08-26
- Registry last updated
- 2025-05-16
- Primary completion date
- 2025-04-16
- Start date
- 2024-09-11
- 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
- NCT06571266
- ClinicalTrials.gov ID
- NCT06571266
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
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.
Maximum Observed Serum Concentration (Cmax) of Risankizumab
Timeframe: Up to Day 140
Cmax will be assessed of Risankizumab
Time to Cmax (Tmax) of Risankizumab
Timeframe: Up to Day 140
Tmax will be assessed of Risankizumab
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
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
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
AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab
Timeframe: Up to Day 140
AUC0-inf will be assessed of Risankizumab
Number of Anti-drug antibody (ADA) Titers
Timeframe: Up to Day 140
Incidence and concentration of anti-drug antibodies
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Healthy volunteers
- Yes
- 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.
- Cenexel Act /ID# 270310Anaheim, United States
- Collaborative Neuroscience Research CNS /ID# 270286Los Alamitos, United States
- Acpru /Id# 270152Grayslake, United States