Status:
TERMINATED
Study of Ixekizumab in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03848403
Start Date
January 29 2019
End Date
July 18 2019
Last Update
November 30 2022
Active Locations (2)
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1
Covance
Dallas, Texas, United States, 75247-4989
2
Covance Clinical Research Inc
Madison, Wisconsin, United States, 53704