A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

February 16, 2024 updated by: Eli Lilly and Company

A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects

This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9LH
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
  • Have medical test results that are acceptable for the study
  • Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

  • Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
  • Have known allergies to compounds or drugs similar to Mirikizumab
  • Have previously participated or withdrawn from this study
  • Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirikizumab Test Subcutaneous (SC) 1
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
Biological: Mirikizumab Test
Administered SC
Other Names:
  • LY3074828
Biological: Mirikizumab Test
Administered IV
Other Names:
  • LY3074828
Experimental: Mirikizumab Test SC 2
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
Biological: Mirikizumab Test
Administered SC
Other Names:
  • LY3074828
Biological: Mirikizumab Test
Administered IV
Other Names:
  • LY3074828
Experimental: Mirikizumab Test Intravenous (IV)
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
Biological: Mirikizumab Test
Administered SC
Other Names:
  • LY3074828
Biological: Mirikizumab Test
Administered IV
Other Names:
  • LY3074828
Active Comparator: Mirikizumab Reference
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants
Biological: Mirikizumab Reference
Administered SC
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
Time Frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC[0-∞]) of Mirikizumab
0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
Time Frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
Time Frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

April 3, 2018

Study Completion (Actual)

April 3, 2018

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16542
  • I6T-MC-AMAL (Other Identifier: Eli Lilly and Company)
  • 2016-003584-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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