A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT07446101
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Mirikizumab — DRUG
    Administered SC

Study Details

The main purpose of this study is to assess the safety and tolerability of mirikizumab (LY3074828) solution formulation administered as a single injection compared with two injections under the skin in healthy participants. Blood tests will be performed to investigate how the body processes the study drug. For each participant, the study will last about 15 weeks.

Key Dates

Start date
Mar 24, 2026
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Mirikizumab (Test Arm 1)
    Mirikizumab administered subcutaneously (SC)
  • Experimental: Mirikizumab (Test Arm 2)
    Mirikizumab administered SC
  • Experimental: Mirikizumab (Reference Arm)
    Mirikizumab administered SC

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 [ Time Frame: Day 1 through Day 71 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (5)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research UnitDaytona BeachFlorida32117
866-429-3700
Kathleen Doisy (PRINCIPAL_INVESTIGATOR)
Axis Clinicals LLCDilworthMinnesota56529
218-284-2947, Option 2
John Mickelson (PRINCIPAL_INVESTIGATOR)
Fortrea Clinical Research UnitDallasTexas75247
866-429-3700
Archie Bowie (PRINCIPAL_INVESTIGATOR)
Worldwide Clinical Trials, Inc.San AntonioTexas78217
210-635-1500
Alan Hand (PRINCIPAL_INVESTIGATOR)
Fortrea Clinical Research UnitMadisonWisconsin53704
866-429-3700
Kimberly Cruz (PRINCIPAL_INVESTIGATOR)

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Fortrea Clinical Research Unit· Daytona Beach, FLAxis Clinicals LLC· Dilworth, MNFortrea Clinical Research Unit· Dallas, TXWorldwide Clinical Trials, Inc.· San Antonio, TXFortrea Clinical Research Unit· Madison, WI

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