A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05515601

17327 (Other Identifier)

I6T-MC-AMBT (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector compared to mirikizumab (reference) solution given via autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Enrollment: 396 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who are overtly healthy as determined by medical evaluation
• Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.
• are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).

Exclusion criteria

• Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy
• Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator
• Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing
• Are lactating or pregnant

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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396 participants in 2 patient groups

Mirikizumab (Reference)

Experimental group

Description:

200 milligram (mg) of mirikizumab as reference formulation \[100 mg/milliliter (mL)\], 2 × 1-mL autoinjector administered as a subcutaneous (SC) injection into the arm/thigh/abdomen on day 1.

Treatment:

Drug: Mirikizumab

Mirikizumab (Test)

Experimental group

Description:

200 mg of mirikizumab as test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.

Treatment:

Drug: Mirikizumab