Clinical trial
A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes
Name
M24-696
Description
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).
Trial arms
Trial start
2023-11-20
Estimated PCD
2024-05-06
Trial end
2024-05-06
Status
Completed
Phase
Early phase I
Treatment
Risankizumab
Infusion; intravenous
Arms:
Arm 1, Arm 2
Size
48
Primary endpoint
Maximum Observed Serum Concentration (Cmax)
Up to Day 131
Time to Cmax (Tmax)
Up to Day 131
Apparent Terminal Phase Elimination Rate Constant (β)
Up to Day 131
Terminal Phase Elimination Half-life (t1/2)
Up to Day 131
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
Up to Day 131
AUC from Time 0 to Infinity (AUC0-inf)
Up to Day 131
Number of Participants with Adverse Events (AEs)
Baseline to Day 141
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}
Updated at
2024-05-14
1 organization
1 product
1 indication
Organization
AbbVieProduct
RisankizumabIndication
Healthy Control Participants