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Completed

NCT Number: NCT02568423

A Study of Mirikizumab (LY3074828) in Healthy Participants

The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. The study is expected to last about 16 weeks for each participant.

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Key information

Conditions

Healthy

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are overtly healthy males or females, as determined by medical history and physical examination.
  • Are first generation Japanese or are Caucasian.
  • Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.
  • Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.

Exclusion criteria

  • Have had symptomatic herpes zoster within 3 months of screening.
  • Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.
  • Have received live vaccine(s) within 1 month of screening or intend to during the study.
  • Are immunocompromised.
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.

Treatment and study plan

Mirikizumab - IV

Drug

Administered IV

Other names: LY3074828

Mirikizumab - SC

Drug

Administered SC

Other names: LY3074828

Placebo - IV

Drug

Administered IV

Placebo - SC

Drug

Administered SC

Primary outcomes

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through Day 85

    SAE is any adverse event (AE) from this study that results in one of the following outcomes:

    • death
    • initial or prolonged inpatient hospitalization
    • a life-threatening experience (that is, immediate risk of dying)
    • persistent or significant disability/incapacity
    • congenital anomaly/birth defect
    • considered significant by the investigator for any other reason

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab

    Time frame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration

    Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab.

  2. Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab

    Time frame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration

    Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2015
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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