A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants

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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

396 participants in 2 patient groups

Mirikizumab Solution (Reference)
Experimental group
Description:
Mirikizumab administered subcutaneously (SC) via an autoinjector (AI) at 3 different injection sites (arm, thigh, and abdomen).
Treatment:
Drug: Mirikizumab
Mirikizumab Solution (Test)
Experimental group
Description:
Mirikizumab administered SC via an AI at 3 different injection sites (arm, thigh, and abdomen).
Treatment:
Drug: Mirikizumab

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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