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

• Status: Completed
• Trial end date: 2024-05-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AbbVie

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.