A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes

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).

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.