A Study of Two Formulations of Ixekizumab in Healthy Participants

  • STATUS
    Recruiting
  • participants needed
    216
  • sponsor
    Eli Lilly and Company
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Updated on 19 February 2024
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Summary

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.

Details
Condition Healthy
Age 18years - 75years
Treatment Ixekizumab
Clinical Study IdentifierNCT04259346
SponsorEli Lilly and Company
Last Modified on19 February 2024

Eligibility

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Inclusion Criteria

Are healthy male or female participants who agree not to become pregnant or are 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

Exclusion Criteria

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
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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