NCT02568423

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

October 2, 2015

Results QC Date

May 5, 2023

Last Update Submit

February 6, 2024

Conditions

Healthy

Outcome Measures

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

    SAE is any adverse event (AE) from this study that results in one of the following outcomes: 1. death 2. initial or prolonged inpatient hospitalization 3. a life-threatening experience (that is, immediate risk of dying) 4. persistent or significant disability/incapacity 5. congenital anomaly/birth defect 6. considered significant by the investigator for any other reason

    Baseline through Day 85

Secondary Outcomes (2)

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

    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

    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

Study Arms (4)

Mirikizumab IV

EXPERIMENTAL

Participants received 200mg Mirikizumab by intravenously.

Drug: Mirikizumab - IV

Mirikizumab SC

EXPERIMENTAL

Participants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously.

Drug: Mirikizumab - SC

Placebo IV

PLACEBO COMPARATOR

Participants received placebo by intravenously.

Drug: Placebo - IV

Placebo SC

PLACEBO COMPARATOR

Participants received placebo by subcutaneously.

Drug: Placebo - SC

Interventions

Mirikizumab - IVDRUG

Administered IV

Also known as: LY3074828
Mirikizumab IV
Mirikizumab - SCDRUG

Administered SC

Also known as: LY3074828
Mirikizumab SC
Placebo - IVDRUG

Administered IV

Placebo IV
Placebo - SCDRUG

Administered SC

Placebo SC

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

mirikizumab

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

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

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 5, 2015

Study Start

December 2, 2015

Primary Completion

July 16, 2018

Study Completion

October 24, 2018

Last Updated

February 8, 2024

Results First Posted

February 8, 2024

Record last verified: 2024-02

Locations

US(1)