A Study of Mirikizumab (LY3074828) in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo - IV; Drug: Placebo - SC; Drug: Mirikizumab - SC; Drug: Mirikizumab - IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02568423

16172

I6T-JE-AMAD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 4 patient groups, including a placebo group

Mirikizumab IV

Experimental group

Description:

Participants received 200mg Mirikizumab by intravenously.

Treatment:

Drug: Mirikizumab - IV

Mirikizumab SC

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab - SC

Placebo IV

Placebo Comparator group

Description:

Participants received placebo by intravenously.

Treatment:

Drug: Placebo - IV

Placebo SC

Placebo Comparator group

Description:

Participants received placebo by subcutaneously.

Treatment:

Drug: Placebo - SC