- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06054425
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
December 19, 2023 updated by: AbbVie
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
106
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ABBVIE CALL CENTER
- Phone Number: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Study Locations
-
-
California
-
Anaheim, California, United States, 92801-2658
- Anaheim Clinical Trials LLC /ID# 260740
-
-
Florida
-
Miami, Florida, United States, 33014
- Clinical Pharmacology of Miami /ID# 260800
-
-
Illinois
-
Grayslake, Illinois, United States, 60030
- Acpru /Id# 260864
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Participants will receive risankizumab manufactured with using the current process (CMC2).
|
Infusion; intravenous
|
Active Comparator: Arm 2
Participants will receive risankizumab manufactured with using the new process (CMC3).
|
Infusion; intravenous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Serum Concentration (Cmax)
Time Frame: Up to Day 131
|
Cmax will be assessed.
|
Up to Day 131
|
Time to Cmax (Tmax)
Time Frame: Up to Day 131
|
Tmax will be assessed.
|
Up to Day 131
|
Apparent Terminal Phase Elimination Rate Constant (β)
Time Frame: Up to Day 131
|
Apparent terminal phase elimination rate constant (β) will be assessed.
|
Up to Day 131
|
Terminal Phase Elimination Half-life (t1/2)
Time Frame: Up to Day 131
|
Terminal phase elimination half-life (t1/2) will be assessed.
|
Up to Day 131
|
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
Time Frame: Up to Day 131
|
AUC0-t will be assessed.
|
Up to Day 131
|
AUC from Time 0 to Infinity (AUC0-inf)
Time Frame: Up to Day 131
|
AUC0-inf will be assessed.
|
Up to Day 131
|
Number of Participants with Adverse Events (AEs)
Time Frame: 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.
|
Baseline to Day 141
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ABBVIE INC., AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2023
Primary Completion (Estimated)
July 4, 2024
Study Completion (Estimated)
July 4, 2024
Study Registration Dates
First Submitted
September 20, 2023
First Submitted That Met QC Criteria
September 20, 2023
First Posted (Actual)
September 26, 2023
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M24-696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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