← Back to all trials
Recruiting
NCT05644353
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
Conditions: Healthy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 410
Sponsor: Eli Lilly and Company
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Participants who are overtly healthy as determined by medical evaluationHave 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 atopyHave an abnormal blood pressure, pulse rate, or temperature as determined by the investigatorIntend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosingAre lactating or pregnant
Source: ClinicalTrials.gov (NCT05644353). StuddyBuddy aggregates publicly available trial information.