Study of Ixekizumab in Healthy Participants

Stopped early · Phase 1

Conditions studied: Healthy

In brief

The purpose of this study is to compare the tolerability of injections of each of 3 formulations of ixekizumab using a prefilled syringe. Information about any side effects (including injection site reactions \[ISRs\]) will be collected.

Key facts

Study ID

NCT03848403

Run by

Eli Lilly and Company

People needed

70

Starts

2019-01-29

Expected to finish

2019-07-18

Last updated by the study team

2022-11-30

Who can join

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

You may qualify if…

• Healthy male participants or female participants who agree not to get pregnant
• Are male participants or female participants with chronic, stable medical problems that, in the investigator's opinion, will not place the participant 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
• Have dullness or loss of sensitivity on either side of your abdomen
• Have any condition that could affect pain perception from an injection
• 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 excessive tattoos or scars over the abdomen or other factors such as rash or excessive folds of skin that would interfere with injection site assessments
• 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 if participating in the study

Where it is running

• Covance — Dallas, Texas, United States
• Covance Clinical Research Inc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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