A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using Investigational 1-mL and 2-mL Prefilled Syringes and Mirikizumab Test Solution Formulation Using Investigational 1-mL and 2-mL Prefilled Syringes in Healthy Participants

17773

The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

2022-12-05

2023-05-25

2023-05-25

Completed

Early phase I

456

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation * Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive. * Are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP). Exclusion Criteria: * Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy * Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator * Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing * Are lactating or pregnant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 456, 'type': 'ACTUAL'}}

2023-06-22