A Study of Two Formulations of Ixekizumab in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved. This study will compare how much of each formulation gets into the blood stream. Information about any side effects that may occur will also be collected. The study will last up to about four months for each participant.

Key facts

Study ID

NCT04259346

Run by

Eli Lilly and Company

People needed

245

Starts

2020-02-05

Expected to finish

2021-02-19

Last updated by the study team

2022-04-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Are healthy male or female participants, with chronic stable medical problems, that in the investigator's opinion will not place the subject at increased risk by participating in the study

You may not qualify if…

• Have a significant history of, or current, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of the investigator poses an unacceptable risk to the participant if participating in the study
• Are allergic or hypersensitive to the study medicine
• Had a vaccination with a live vaccine within 12 months prior to the first check-in or intend to get a vaccine for tuberculosis within 12 months of completing treatment on this study
• Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other serious infection
• Show evidence of active or latent tuberculosis (TB)
• Presence of significant neuropsychiatric disorder or a recent history of depression
• Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion of the investigator, would pose an unacceptable risk to the participant

Where it is running

• Covance Clinical Research Inc — Daytona Beach, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Covance Dallas — Dallas, Texas, United States
• Covance Clinical Research Inc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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