A Study to Compare Two Different Formulations of Mirikizumab in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04548219

17667

I6T-MC-AMBV (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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
• Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Mirikizumab (Reference)

Experimental group

Description:

200 milligram (mg) of mirikizumab as reference formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.

Treatment:

Drug: Mirikizumab

Mirikizumab (Test)

Experimental group

Description:

200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL pre-filled syringe administered as a SC injection into the arm/thigh/abdomen on day 1.

Treatment:

Drug: Mirikizumab