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A Study of Mirikizumab (LY3074828) in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568423
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Mirikizumab - IV Drug: Mirikizumab - SC Drug: Placebo - IV Drug: Placebo - SC Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects
Actual Study Start Date : November 4, 2015
Actual Primary Completion Date : May 13, 2016
Actual Study Completion Date : July 16, 2018

Arm Intervention/treatment
Experimental: Mirikizumab IV
Mirikizumab given by intravenous (IV) infusion once.
Drug: Mirikizumab - IV
Administered IV
Other Name: LY3074828

Experimental: Mirikizumab SC
Mirikizumab given by subcutaneous (SC) injection once.
Drug: Mirikizumab - SC
Administered SC
Other Name: LY3074828

Placebo Comparator: Placebo IV
Placebo given by IV infusion once.
Drug: Placebo - IV
Administered IV

Placebo Comparator: Placebo SC
Placebo given by SC injection once.
Drug: Placebo - SC
Administered SC




Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Mirikizumab [ Time Frame: Baseline through Day 85 ]
  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Mirikizumab [ Time Frame: Baseline through Day 85 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568423


Locations
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United States, California
WCCT Global
Cypress, California, United States, 90630
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02568423    
Other Study ID Numbers: 16172
I6T-JE-AMAD ( Other Identifier: Eli Lilly and Company )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018