A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Mirikizumab Test; Biological: Mirikizumab Reference

Study type: Interventional

Funder types: Industry

Identifiers

NCT03053622

I6T-MC-AMAL (Other Identifier)

16542

2016-003584-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously participated or withdrawn from this study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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 4 patient groups

Mirikizumab Test Subcutaneous (SC) 1

Experimental group

Description:

250 mg mirikizumab test formulation given as a single injection SC in healthy participants

Treatment:

Biological: Mirikizumab Test

Biological: Mirikizumab Test

Mirikizumab Test SC 2

Experimental group

Description:

250 mg mirikizumab test formulation given as two injections given SC in healthy participants

Treatment:

Biological: Mirikizumab Test

Biological: Mirikizumab Test

Mirikizumab Test Intravenous (IV)

Experimental group

Description:

250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants

Treatment:

Biological: Mirikizumab Test

Biological: Mirikizumab Test

Mirikizumab Reference

Active Comparator group

Description:

250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants

Treatment:

Biological: Mirikizumab Reference