A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants

NCT06475729 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18852I6T-MC-AMCB
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab

  Cmax of Mirikizumab is reported.

  Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

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

  AUC \[0-∞\] of Mirikizumab is reported.

  Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

• PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab

  AUC \[0 to tlast\] of Mirikizumab is reported.

  Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Study Arms (2)

200 mg Mirikizumab (Test)

EXPERIMENTAL

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.

Drug: Citrate-Free Mirikizumab

200 mg Mirikizumab (Reference)

EXPERIMENTAL

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.

Drug: Citrate-Free Mirikizumab

Interventions

Citrate-Free Mirikizumab DRUG

Administered SC

Also known as: LY3074828

200 mg Mirikizumab (Reference); 200 mg Mirikizumab (Test)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

CenExel ACT

Anaheim, California, 92801, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014-3616, United States

Location

QPS Missouri

Springfield, Missouri, 65802, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• Otani Y, Payne CD, Loftus EV Jr, D'Haens G, Ben Horin S, Upadhya K A, Todd K, Pellanda P, Shi G, Zhang X. One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. Adv Ther. 2026 Jan;43(1):377-389. doi: 10.1007/s12325-025-03422-1. Epub 2025 Nov 28.

  PMID: 41313544 DERIVED

MeSH Terms

Interventions

mirikizumab

Results Point of Contact

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

ClinicalTrials.gov@lilly.com

08005455979

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: June 24, 2024
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)