A Study of Mirikizumab in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Mirikizumab - IV; Drug: Placebo - SC; Drug: Placebo - IV; Drug: Mirikizumab - SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04137380

I6T-MC-AMBD (Other Identifier)

16766

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug. It will last up to about 4 months for each participant.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Native Chinese (all 4 biological grandparents and both biological parents to be Chinese origin)
• Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at time of screening
• Have clinical laboratory test results within normal reference range for the investigative site or results with acceptable deviations that are judged to be not clinically significant by the investigator
• Have venous access sufficient to allow for blood sampling and administration of investigational product (IP) or placebo
• Are reliable and willing to be available for the duration of the study and are willing to follow study procedures
• Are able and willing to give signed informed consent

Exclusion criteria

• Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have participated in a clinical trial involving an IP within 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 Day 1
• Have known allergies to LY3074828, humanized monoclonal antibodies, related compounds or any components of the formulation, or history of significant atopy
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C and/or positive hepatitis C antibody
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen or positive hepatitis B core antibody
• Have had symptomatic herpes zoster within 3 months of screening
• Show evidence of active or latent tuberculosis (TB), as documented by medical history, examination, chest X-rays (posterior/anterior and lateral), and TB testing (positive or indeterminate for QuantiFERON® -TB Gold test or T-Spot. 1 retest permitted following indeterminate result); or have had household contact with a person with active TB, unless appropriate and documented prophylaxis treatment has been given. Participants with any history of active TB are excluded from the study, regardless of previous or current TB treatments.
• Have received live vaccine(s), including attenuated live vaccines and those administered intranasally, within 8 weeks of screening, or intend to during the study
• Are immunocompromised
• Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Mirikizumab - Intravenous (IV)

Experimental group

Description:

Participants received a single dose of 300 milligram (mg), 600 mg and 1200 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes, 60 minutes and 2 hours.

Treatment:

Drug: Mirikizumab - IV

Placebo - IV

Placebo Comparator group

Description:

Participants received a single dose of placebo administered IV using a forearm vein.

Treatment:

Drug: Placebo - IV

Mirikizumab - Subcutaneous (SC)

Experimental group

Description:

Participants received a single dose of 200 mg, 400 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).

Treatment:

Drug: Mirikizumab - SC

Placebo - SC

Placebo Comparator group

Description:

Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).

Treatment:

Drug: Placebo - SC