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OpenTrials
Completed

NCT Number: NCT03053622

A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

Mirikizumab Test

Biological

Administered SC

Other names: LY3074828

Mirikizumab Reference

Biological

Administered SC

Other names: LY3074828

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2017
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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