A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

NCT05644353
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Phase
Phase 1
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Recruitment status
Completed
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Participants
450
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Lead sponsor
Eli Lilly and Company
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Start date
2022-12-05
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Number of sites
6
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Summary
The main purpose of this study is to evaluate 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 pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.
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Short title
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
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Official title
A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using Investigational 1-mL and 2-mL Prefilled Syringes and Mirikizumab Test Solution Formulation Using Investigational 1-mL and 2-mL Prefilled Syringes in Healthy Participants
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-05-25
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First posted
2022-12-09
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Registry last updated
2025-03-28
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Primary completion date
2023-05-25
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Start date
2022-12-05
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Actual participants
450
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Participants
450
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
6
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05644353
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ClinicalTrials.gov ID
NCT05644353
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
Single masking
Masked roles
Participants
Sources for study design
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  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation

    Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose

    PK: Cmax of Mirikizumab

  2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation

    Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose

    PK: AUC\[0-∞\] of Mirikizumab

  3. PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab in a Citrate-free Solution Formulation Compared to the Solution Formulation

    Timeframe: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 and, 2040 hours post day 1 dose

    PK: AUC\[0-tlast\] of Mirikizumab

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • Participants who are overtly healthy as determined by medical evaluation
  • Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.
  • Are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).

  • Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy
  • Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator
  • Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing
  • Are lactating or pregnant
Sources for eligibility
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  • Altasciences Clinical Los Angeles, IncCypress, United States
  • LabCorp CRU, Inc.Daytona Beach, United States
  • Clinical Pharmacology of MiamiMiami, United States
  • Qps-Mra, LlcMiami, United States
  • AxisDilworth, United States
  • Labcorp Clinical Research LPDallas, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • I6T-MC-AMBY
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (2)