A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Risankizumab
- Conditions
- Healthy Volunteers
- Sponsor
- AbbVie
- Enrollment
- 394
- Locations
- 8
- Primary Endpoint
- Percentage of Participants Experiencing Adverse Events (AEs)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body weight less than 100.00 kg at Screening and upon initial confinement.
Exclusion Criteria
- •Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
Arms & Interventions
Group 1: Risankizumab Dose A
Participants will receive risankizumab dose A.
Intervention: Risankizumab
Group 2: Risankizumab Dose B
Participants will receive risankizumab dose B.
Intervention: Risankizumab
Group 3: Risankizumab Dose C
Participants will receive risankizumab dose C.
Intervention: Risankizumab
Group 4: Risankizumab Dose D
Participants will receive risankizumab dose D.
Intervention: Risankizumab
Group 5: Risankizumab Dose D
Participants will receive risankizumab dose D.
Intervention: Risankizumab
Outcomes
Primary Outcomes
Percentage of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 140 days
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. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Serum Concentration (Cmax)
Time Frame: Up to approximately 113 days
Maximum observed serum concentration (Cmax) of risankizumab.
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
Time Frame: Up to approximately 113 days
AUCt of risankizumab.
AUC From Time 0 to Infinity (AUCinf)
Time Frame: Up to approximately 113 days
AUCinf of risankizumab.
Time to Cmax (Tmax)
Time Frame: Up to approximately 113 days
Time to Cmax of risankizumab.
Apparent Terminal Phase Elimination Rate Constant (β)
Time Frame: Up to approximately 113 days
Apparent terminal phase elimination rate constant (β) of risankizumab.
Terminal Phase Elimination Hhalf-life (t1/2)
Time Frame: Up to approximately 113 days
Terminal phase elimination half-life (t1/2) of risankizumab.