A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants
A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants
The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector.
Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Anaheim, California, United States, 92801
- CenExel ACT
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Florida
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Daytona Beach, Florida, United States, 32117
- Fortrea Clinical Research Unit
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Miami, Florida, United States, 33014-3616
- Clinical Pharmacology of Miami
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Missouri
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Springfield, Missouri, United States, 65802
- QPS Missouri
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Texas
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Dallas, Texas, United States, 75247
- Fortrea Clinical Research Unit
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Wisconsin
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Madison, Wisconsin, United States, 53704
- Fortrea Clinical Research Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Type of participant and disease characteristics
Overtly healthy males and females as determined by medical evaluation including:
- Medical history,
- Physical examination,
- Clinical laboratory tests,
- Electrocardiogram (ECG),
- Vital signs
Note: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Have clinical laboratory test results:
- Within normal reference range for the population, or
- Within normal reference range for the investigative site, or
- Results with acceptable deviations that are judged to be not clinically significant by the investigator.
Weight
Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m^2), inclusive.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
- Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation.
- Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
- Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
Have a diagnosis or history of malignant disease within 5 years prior to baseline.
Prior/concomitant therapy
- Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
- Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing.
- Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use.
Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization.
Prior/concurrent clinical study experience
- Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing.
Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab.
Diagnostic assessments
- Have a current infection with hepatitis C virus.
- Have a current infection with hepatitis B virus.
- Have a current or recent acute, active infection.
Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization:
- Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both.
- Opportunistic: As defined in Winthrop et al. 2015. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
- Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer.
- Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis.
Show evidence of active or latent tuberculosis (TB).
Other exclusion criteria
- Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
- Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions.
- In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 200 mg Mirikizumab (Test)
Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
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Administered SC
Other Names:
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Experimental: 200 mg Mirikizumab (Reference)
Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
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Administered SC
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Time Frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
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Cmax of Mirikizumab is reported.
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Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
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PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab
Time Frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
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AUC [0-∞] of Mirikizumab is reported.
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Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
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PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab
Time Frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
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AUC [0 to tlast] of Mirikizumab is reported.
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Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
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Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18852
- I6T-MC-AMCB (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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