A Study of Mirikizumab in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Mirikizumab Autoinjector; Drug: Mirikizumab Prefilled Syringe

• Registration Number: NCT04607733
• Lead Sponsor: Eli Lilly and Company

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 start of the study. For each participant, the total duration of the clinical trial will be about 17 weeks, including screening.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Study Start: 2020-11-02
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-17
• Results First Submitted: 2023-05-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Results First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Are overtly healthy males or females, as determined through medical history and physical examination

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Exclusion Criteria

• Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
• 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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab - Autoinjector	Mirikizumab Autoinjector	2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI)
Mirikizumab - Prefilled Syringe	Mirikizumab Prefilled Syringe	2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab	Predose up to 85 days postdose	PK: Cmax of Mirikizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab	Predose up to 85 days postdose	PK: AUC\[0-tlast\] of Mirikizumab
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab	Predose up to 85 days postdose	PK: AUC\[0-∞\] of Mirikizumab

Trial Locations

Locations (3)

QPS; 🇺🇸 Springfield, Missouri, United States

Covance Dallas; 🇺🇸 Dallas, Texas, United States

Covance Clinical Research Inc; 🇺🇸 Madison, Wisconsin, United States