A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05515601
• Other study ID #: 17327
• Secondary ID: I6T-MC-AMBT
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Mirikizumab
Administered SC.

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California
United States	Labcorp Clinical Research LP	Dallas	Texas
United States	LabCorp CRU, Inc.	Daytona Beach	Florida
United States	Axis	Dilworth	Minnesota
United States	LabCorp CRU, Inc.	Madison	Wisconsin
United States	QPS	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab	PK: Maximum Concentration (Cmax) of Mirikizumab	Predose up to 85 days postdose
Primary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of Mirikizumab	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of Mirikizumab	Predose up to 85 days postdose
Primary	PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab	PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration AUC[0-tlast] of Mirikizumab	Predose up to 85 days postdose