A Study of Mirikizumab in Healthy Chinese Participants

NCT ID: NCT04137380

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-04
• Study Completion Date: 2020-12-11

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Mirikizumab - Intravenous (IV)

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.

Group Type: EXPERIMENTAL

Mirikizumab - IV

Intervention Type: DRUG

Administered IV

Placebo - IV

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

Group Type: PLACEBO_COMPARATOR

Placebo - IV

Intervention Type: DRUG

Administered IV

Mirikizumab - Subcutaneous (SC)

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).

Group Type: EXPERIMENTAL

Mirikizumab - SC

Intervention Type: DRUG

Administered SC

Placebo - SC

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).

Group Type: PLACEBO_COMPARATOR

Placebo - SC

Intervention Type: DRUG

Administered SC

Interventions

Mirikizumab - IV

Administered IV

Intervention Type: DRUG

Mirikizumab - SC

Administered SC

Intervention Type: DRUG

Placebo - IV

Administered IV

Intervention Type: DRUG

Placebo - SC

Administered SC

Intervention Type: DRUG

Other Intervention Names

LY3074828; LY3074828

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Shanghai Xuhui Central Hospital

Xuhui District, Shanghai Municipality, China

Peking University First Hospital

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I6T-MC-AMBD

Identifier Type: OTHER

Identifier Source: secondary_id

16766

Identifier Type: -

Identifier Source: org_study_id