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

NCT05069896 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18139I6T-MC-AMBX
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  PK: Cmax of Mirikizumab administered by PFS and AI.

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

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

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

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

• 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

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

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

Study Arms (2)

Mirikizumab - Prefilled Syringe

EXPERIMENTAL

Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via a prefilled syringe (PFS) to abdomen or arms or thighs.

Drug: Mirikizumab Prefilled Syringe

Mirikizumab - Autoinjector

EXPERIMENTAL

Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered an autoinjector (AI) to abdomen or arms or thighs.

Drug: Mirikizumab Autoinjector

Interventions

Mirikizumab Prefilled Syringe DRUG

Administered SC by prefilled syringe

Also known as: LY3074828

Mirikizumab - Prefilled Syringe

Mirikizumab Autoinjector DRUG

Administered SC by autoinjector

Also known as: LY3074828

Mirikizumab - Autoinjector

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

LabCorp CRU, Inc.

Daytona Beach, Florida, 32117, United States

Location

QPS

Springfield, Missouri, 65802, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

Related Publications (1)

• Zhang X, Otani Y, Payne CD, Morris NJ, Chua L, Escobar R, Wang S, Shi G. Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants. Adv Ther. 2025 Nov;42(11):5529-5546. doi: 10.1007/s12325-025-03335-z. Epub 2025 Sep 3.

  PMID: 40900263 DERIVED

MeSH Terms

Interventions

mirikizumab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 6, 2021
• Study Start: October 5, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)