A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Mirikizumab

• Registration Number: NCT05515601
• Lead Sponsor: Eli Lilly and Company

Brief 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 autoinjector compared to mirikizumab (reference) solution given via autoinjector. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-25
• Study Start: 2022-08-31
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Status Verified: 2024-01
• Results First Submitted: 2024-01-22
• Results First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Results First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab (Test)	Mirikizumab	200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
Mirikizumab (Reference)	Mirikizumab	200 milligram (mg) of mirikizumab as reference formulation \[100 mg/milliliter (mL)\], 2 × 1-mL autoinjector administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab	Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose	PK: Cmax of mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab	Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose	PK: AUC\[0-∞\] of Mirikizumab was evaluated.
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab	Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose	PK: AUC\[0-tlast\] of Mirikizumab was evaluated.

Trial Locations

Locations (5)

Altasciences Clinical Los Angeles, Inc; 🇺🇸 Cypress, California, United States

LabCorp CRU, Inc.; 🇺🇸 Madison, Wisconsin, United States

Axis; 🇺🇸 Dilworth, Minnesota, United States

QPS; 🇺🇸 Springfield, Missouri, United States

Labcorp Clinical Research LP; 🇺🇸 Dallas, Texas, United States