A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05515601

Collaborator

(none)

396

Enrollment

Locations

Arms

5.7

Anticipated Duration (Months)

Patients Per Site

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Mirikizumab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

396 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

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

Anticipated Study Start Date :

Sep 2, 2022

Anticipated Primary Completion Date :

Feb 21, 2023

Anticipated Study Completion Date :

Feb 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mirikizumab Solution (Reference) Mirikizumab administered subcutaneously (SC) via an autoinjector (AI) at 3 different injection sites (arm, thigh, and abdomen).	Drug: Mirikizumab Administered SC.
Experimental: Mirikizumab Solution (Test) Mirikizumab administered SC via an AI at 3 different injection sites (arm, thigh, and abdomen).	Drug: Mirikizumab Administered SC.

Arm

Intervention/Treatment

Experimental: Mirikizumab Solution (Reference)

Mirikizumab administered subcutaneously (SC) via an autoinjector (AI) at 3 different injection sites (arm, thigh, and abdomen).

Drug: Mirikizumab

Administered SC.

Experimental: Mirikizumab Solution (Test)

Mirikizumab administered SC via an AI at 3 different injection sites (arm, thigh, and abdomen).

Drug: Mirikizumab

Administered SC.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab [Predose up to 85 days postdose]
PK: Maximum Concentration (Cmax) of Mirikizumab
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab [Predose up to 85 days postdose]
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) 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]
PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration AUC[0-tlast] of Mirikizumab

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altasciences Clinical Los Angeles, Inc	Cypress	California	United States	90630
2	LabCorp CRU, Inc.	Daytona Beach	Florida	United States	32117
3	Axis	Dilworth	Minnesota	United States	56529
4	QPS	Springfield	Missouri	United States	65802
5	Covance Dallas	Dallas	Texas	United States	75247
6	LabCorp CRU, Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05515601

Other Study ID Numbers:

17327
I6T-MC-AMBT

First Posted:

Aug 25, 2022

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mirikizumab

Study Results

No Results Posted as of Aug 25, 2022