A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
Study Details
Study Description
Brief Summary
The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 Participants will receive risankizumab manufactured with using the current process (CMC2). |
Drug: Risankizumab
Infusion; intravenous
|
| Active Comparator: Arm 2 Participants will receive risankizumab manufactured with using the new process (CMC3). |
Drug: Risankizumab
Infusion; intravenous
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Serum Concentration (Cmax) [Up to Day 131]
Cmax will be assessed.
- Time to Cmax (Tmax) [Up to Day 131]
Tmax will be assessed.
- Apparent Terminal Phase Elimination Rate Constant (β) [Up to Day 131]
Apparent terminal phase elimination rate constant (β) will be assessed.
- Terminal Phase Elimination Half-life (t1/2) [Up to Day 131]
Terminal phase elimination half-life (t1/2) will be assessed.
- Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) [Up to Day 131]
AUC0-t will be assessed.
- AUC from Time 0 to Infinity (AUC0-inf) [Up to Day 131]
AUC0-inf will be assessed.
- Number of Participants with Adverse Events (AEs) [Baseline to Day 141]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body Mass Index (BMI) >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal at the time of screening and upon initial 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 electrocardiogram (ECG).
-
Body weight less than 100.00 kg at Screening and upon initial confinement.
Exclusion Criteria:
-
History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
-
Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- M24-696