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A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548219
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.

Condition or disease Intervention/treatment Phase
Healthy Drug: Mirikizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects
Actual Study Start Date : September 15, 2020
Actual Primary Completion Date : January 11, 2021
Actual Study Completion Date : January 11, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mirikizumab (Reference)
Reference formulation of mirikizumab administered as a subcutaneous (SC) injection.
 Drug: Mirikizumab
Administered SC.
Other Name: LY3074828
Experimental: Mirikizumab (Test)
Test formulation of mirikizumab administered as a SC injection.
 Drug: Mirikizumab
Administered SC.
Other Name: LY3074828


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab [ Time Frame: Predose on Day 1 through Day 85 ]
    PK: Cmax of Mirikizumab

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Mirikizumab [ Time Frame: Predose on Day 1 through Day 85 ]
    PK: AUC(0-inf) of Mirikizumab


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined through medical history and physical examination

Exclusion Criteria:

  • Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
  • Must not show evidence of active or latent tuberculosis (TB)
  • Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
  • Must not have been treated with steroids within 1 month of screening, or intend to during the study
  • Must not be immunocompromised
  • Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
  • Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
  • Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Must not have had breast cancer within the past 10 years
  • Must not have significant allergies to humanized monoclonal antibodies
  • Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548219


Locations
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United States, Missouri
QPS
Springfield, Missouri, United States, 65802
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04548219    
Other Study ID Numbers: 17667
I6T-MC-AMBV ( Other Identifier: Eli Lilly and Company )
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mirikizumab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents