A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Mirikizumab Test; Biological: Mirikizumab Reference

• Registration Number: NCT03053622
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-15
• Study Start: 2017-04-24
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-03
• Results First Submitted: 2023-05-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Results First Posted: 2024-02-21
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

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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• Have previously participated or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab Test Subcutaneous (SC) 1	Mirikizumab Test	250 mg mirikizumab test formulation given as a single injection SC in healthy participants
Mirikizumab Test SC 2	Mirikizumab Test	250 mg mirikizumab test formulation given as two injections given SC in healthy participants
Mirikizumab Test Intravenous (IV)	Mirikizumab Test	250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
Mirikizumab Reference	Mirikizumab Reference	250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants

Primary Outcome Measures

Name	Time	Method
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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab

Secondary Outcome Measures

Name	Time	Method
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: Maximum Observed Concentration (Cmax) of Mirikizumab
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	PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab

Trial Locations

Locations (1)

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.; 🇬🇧 Leeds, West Yorkshire, United Kingdom