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Clinical trial

A Phase 1, Open-label Study to Assess PK Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

ID
Name
M24-460
Description
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
Trial arms
Trial start
2024-07-09
Estimated PCD
2025-04-29
Trial end
2025-04-29
Status
Not yet recruiting
Phase
Early phase I
Treatment
Risankizumab
Intravenous (IV) Infusion
Arms:
Risankizumab Dose A for Intravenous (IV) Infusion
Other names:
ABBV-066, SKYRIZI
Risankizumab
Subcutaneous (SC) Injection
Arms:
Risankizumab Dose B for Subcutaneous (SC) Injection
Other names:
ABBV-066, SKYRIZI
Size
60
Primary endpoint
Number of Participants Experiencing Adverse Events
Up to approximately 140 days
Maximum Observed Serum Concentration (Cmax) of Risankizumab
Up to approximately 140 days
Time to Cmax (Tmax) of Risankizumab
Up to approximately 140 days
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab
Up to approximately Week 4
Eligibility criteria
Inclusion Criteria: * Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight greater than 40 kg and less than 100 kg at 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 ECG Exclusion Criteria: * Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening. * Intention to perform strenuous exercise to which the particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-07-04

1 organization

1 product

1 indication

Organization
AbbVie
Product
Risankizumab
Indication
Healthy Control Participants