A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

Eli Lilly and Company396 enrolled

Overview

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 autoinjector compared to mirikizumab (reference) solution given via autoinjector. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

396

Conditions

Healthy

Interventions

MirikizumabDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

LabCorp CRU, Inc.

Daytona Beach, Florida, United States

Axis

Dilworth, Minnesota, United States

QPS

Springfield, Missouri, United States

Outcomes

Primary Outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab

PK: Cmax of mirikizumab was evaluated.

Time frame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab

PK: AUC\[0-∞\] of Mirikizumab was evaluated.

Time frame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab

PK: AUC\[0-tlast\] of Mirikizumab was evaluated.

Time frame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose

Data from ClinicalTrials.gov

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