Status:
COMPLETED
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06054425
Start Date
November 20 2023
End Date
May 6 2024
Last Update
May 14 2024
Active Locations (3)
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1
Anaheim Clinical Trials LLC /ID# 260740
Anaheim, California, United States, 92801-2658
2
Clinical Pharmacology of Miami /ID# 260800
Miami, Florida, United States, 33014
3
Acpru /Id# 260864
Grayslake, Illinois, United States, 60030