A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles, Inc, Cypress, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirikizumab

Drug

Administered SC.

Primary outcomes

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

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

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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Aug 25, 2022
Registry last updated: Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed