Status:
COMPLETED
A 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 three different formulations of ixekizumab. One formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two formulations (Test 1...
Eligibility Criteria
Inclusion
- Healthy male participant or female participant who agree to not become pregnant
- Are male participant 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
- 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, if participating in the study
Key Trial Info
Start Date :
January 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2019
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03848416
Start Date
January 29 2019
End Date
June 7 2019
Last Update
June 24 2020
Active Locations (1)
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1
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117