A Study of Mirikizumab (LY3074828) in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Mirikizumab - IV; Drug: Mirikizumab - SC; Drug: Placebo - IV; Drug: Placebo - SC

• Registration Number: NCT02568423
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Study Start: 2015-12-02
• Primary Completion: 2018-07-16
• Study Completion: 2018-10-24
• Results First Submitted: 2023-05-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Results First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab IV	Mirikizumab - IV	Participants received 200mg Mirikizumab by intravenously.
Mirikizumab SC	Mirikizumab - SC	Participants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously.
Placebo IV	Placebo - IV	Participants received placebo by intravenously.
Placebo SC	Placebo - SC	Participants received placebo by subcutaneously.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
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 (PK): Maximum Concentration (Cmax) of Mirikizumab.
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	Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab.

Trial Locations

Locations (1)

WCCT Global; 🇺🇸 Cypress, California, United States