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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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).

Key facts

Study ID

NCT06054425

Run by

AbbVie

People needed

48

Starts

2023-11-20

Expected to finish

2024-05-06

Last updated by the study team

2024-05-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Anaheim Clinical Trials LLC /ID# 260740 — Anaheim, California, United States
• Clinical Pharmacology of Miami /ID# 260800 — Miami, Florida, United States
• Acpru /Id# 260864 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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