NCT03053622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

February 13, 2017

Results QC Date

May 5, 2023

Last Update Submit

February 16, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab

    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 Outcomes (2)

  • 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

    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

Study Arms (4)

Mirikizumab Test Subcutaneous (SC) 1

EXPERIMENTAL

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

Biological: Mirikizumab Test

Mirikizumab Test SC 2

EXPERIMENTAL

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

Biological: Mirikizumab Test

Mirikizumab Test Intravenous (IV)

EXPERIMENTAL

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

Biological: Mirikizumab Test

Mirikizumab Reference

ACTIVE COMPARATOR

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

Biological: Mirikizumab Reference

Interventions

Mirikizumab TestBIOLOGICAL

Administered SC

Also known as: LY3074828
Mirikizumab Test SC 2Mirikizumab Test Subcutaneous (SC) 1
Mirikizumab ReferenceBIOLOGICAL

Administered SC

Also known as: LY3074828
Mirikizumab Reference

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

mirikizumab

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

April 24, 2017

Primary Completion

April 3, 2018

Study Completion

April 3, 2018

Last Updated

February 21, 2024

Results First Posted

February 21, 2024

Record last verified: 2024-02

Locations

GB(1)