Phase 1 Completed N=60 Randomized Double-blind Basic Science

A Study of Mirikizumab in Healthy Chinese Participants

Healthy

Source: ClinicalTrials.gov NCT04137380 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcomePrimary: Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) — 1; 3; 4; 1 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs)	1; 3; 4; 1; 1; 0	—
PRIMARY Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site	36.5; 30.8; 42.4; 3.5; 2.9; 10.6	—
SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab	145; 266; 511; 14.9; 23.1	—
SECONDARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab	936; 2030; 3320; 263; 421	—
SECONDARY PK: AUC From Time Zero to Time T, Where T is the Last Sample With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab	964; 2010; 3300; 248; 417	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04137380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.