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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05069896
Other study ID # 18139
Secondary ID I6T-MC-AMBX
Status Completed
Phase Phase 1
First received
Last updated
Start date October 5, 2021
Est. completion date June 22, 2022

Study information

Verified date July 4, 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated. Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.


Recruitment information / eligibility

Status Completed
Enrollment 237
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Are overtly healthy males or non-pregnant females of childbearing or non-childbearing potential - Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive) Exclusion Criteria: - Must not show evidence of active or latent tuberculosis (TB) - Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study - Must not have been treated with steroids within 1 month of screening, or intend to during the study - Must not have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1 - Must not be immunocompromised - Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1 - Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions - Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years - Must not have had breast cancer within the past 10 years - Must not have significant allergies to humanized monoclonal antibodies

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mirikizumab Prefilled Syringe
Administered SC by prefilled syringe
Mirikizumab Autoinjector
Administered SC by autoinjector

Locations

Country Name City State
United States Covance Dallas Dallas Texas
United States LabCorp CRU, Inc. Daytona Beach Florida
United States QPS Springfield Missouri

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab PK: Cmax of Mirikizumab Predose up to 85 days postdose
Primary PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Mirikizumab PK: AUC[0-8] of Mirikizumab Predose up to 85 days postdose
Primary PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab PK: AUC[0-tlast] of Mirikizumab Predose up to 85 days postdose
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