A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Healthy Chinese Subjects

A Study of Mirikizumab in Healthy Chinese Participants

Sponsors

Lead sponsor: Eli Lilly and Company

Source Eli Lilly and Company
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.

Overall Status Recruiting
Start Date December 4, 2019
Completion Date June 26, 2020
Primary Completion Date June 26, 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Baseline through Day 85
Secondary Outcome
Measure Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab Baseline through Day 85
PK: AUC from time zero to infinity (AUC[0-∞]) of Mirikizumab Baseline through Day 85
PK: AUC from Time Zero to Time T, where T is the Last Sample with a Measurable Concentration (AUC[0-tlast]) of Mirikizumab Baseline through Day 85
Enrollment 60
Condition
Intervention

Intervention type: Drug

Intervention name: Mirikizumab - IV

Description: Administered IV

Arm group label: Mirikizumab - Intravenous (IV)

Other name: LY3074828

Intervention type: Drug

Intervention name: Mirikizumab - SC

Description: Administered SC

Arm group label: Mirikizumab - Subcutaneous (SC)

Other name: LY3074828

Intervention type: Drug

Intervention name: Placebo - IV

Description: Administered IV

Arm group label: Placebo - IV

Intervention type: Drug

Intervention name: Placebo - SC

Description: Administered SC

Arm group label: Placebo - SC

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)

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Overall Contact

Last name: This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email: [email protected]

Location
facility status contact investigator
Peking University First Hospital Recruiting 010-66110987 Yimin Cui Principal Investigator
Location Countries

China

Verification Date

May 1, 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 4
Arm Group

Arm group label: Mirikizumab - Intravenous (IV)

Arm group type: Experimental

Description: Mirikizumab administered IV

Arm group label: Placebo - IV

Arm group type: Placebo Comparator

Description: Placebo administered IV

Arm group label: Mirikizumab - Subcutaneous (SC)

Arm group type: Experimental

Description: Mirikizumab administered SC

Arm group label: Placebo - SC

Arm group type: Placebo Comparator

Description: Placebo administered SC

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov