Clinical trial NCT05515601: A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
Official title: A Bioequivalence Study of Subcutaneous Injections of Mirikizumab Reference Solution Using an Investigational 1-mL Autoinjector and Mirikizumab Test Solution Formulation Using an Investigational 1-mL Autoinjector in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
timeFrame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
timeFrame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab
timeFrame: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
city: Daytona Beach
country: United States
facility: LabCorp CRU, Inc.
state: Florida
city: Dilworth
country: United States
facility: Axis
state: Minnesota
city: Springfield
country: United States
facility: QPS
state: Missouri
city: Dallas
country: United States
facility: Labcorp Clinical Research LP
state: Texas
city: Madison
country: United States
facility: LabCorp CRU, Inc.
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: