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Clinical trial

A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe

ID
Name
M23-522
Description
This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world. All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations. There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
Trial arms
Trial start
2022-09-28
Estimated PCD
2023-04-20
Trial end
2023-04-20
Status
Completed
Phase
Early phase I
Treatment
Risankizumab Dose A
Prefilled Syringe
Arms:
Risankizumab Dose A
Risankizumab Dose B
Prefilled Syringe
Arms:
Risankizumab Dose B
Size
198
Primary endpoint
Maximum Observed Plasma Concentration (Cmax)
Approximately up to 113 days
Time to Maximum Observed Plasma Concentration (Tmax)
Approximately up to 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
Approximately up to 113 days
The Terminal Phase Elimination Half-Life (t1/2)
Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Approximately up to 113 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Approximately up to 113 days
Number of Participants with Adverse Events
Approximately up to 140 days
Eligibility criteria
Inclusion Criteria: - Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement. Exclusion Criteria: * Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment. * Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 198, 'type': 'ACTUAL'}}
Updated at
2023-04-28

1 organization

1 product

1 indication

Organization
AbbVie
Product
Risankizumab
Indication
Healthy Control Participants