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OpenTrials
Completed

NCT Number: NCT05069896

A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LabCorp CRU, Inc., Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are overtly healthy males or non-pregnant females of childbearing or non-childbearing potential
  • Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive)

Exclusion criteria

  • 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 have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1
  • 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

Treatment and study plan

Mirikizumab Prefilled Syringe

Drug

Administered SC by prefilled syringe

Other names: LY3074828

Mirikizumab Autoinjector

Drug

Administered SC by autoinjector

Other names: LY3074828

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI

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

    PK: Cmax of Mirikizumab administered by PFS and AI.

  2. PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI

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

    PK: AUC[0-∞] of Mirikizumab administered by PFS and AI.

  3. PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI

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

    PK: AUC[0-tlast] of Mirikizumab administered by PFS and AI.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Bioequivalence Study of Injections of Mirikizumab Solution Using Investigational 1-mL and 2-mL Pre-Filled Syringes and Investigational 1-mL and 2-mL Autoinjectors in Healthy Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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