A Study of Mirikizumab in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Mirikizumab Prefilled Syringe; Drug: Mirikizumab Autoinjector

Study type: Interventional

Funder types: Industry

Identifiers

NCT04607733

I6T-MC-AMBW (Other Identifier)

17820

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 65 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Mirikizumab - Prefilled Syringe

Experimental group

Description:

2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via a prefilled syringe (PFS)

Treatment:

Drug: Mirikizumab Prefilled Syringe

Mirikizumab - Autoinjector

Experimental group

Description:

2× 1mL (total 200 milligrams (mg) mirikizumab) administered by subcutaneous injection (SC) via an autoinjector (AI)

Treatment:

Drug: Mirikizumab Autoinjector