Study of Ixekizumab in Healthy Participants
Status: | Recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/5/2019 |
Start Date: | January 29, 2019 |
End Date: | July 24, 2019 |
Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
Email: | ClinicalTrials.gov@lilly.com |
Phone: | 1-317-615-4559 |
A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous Injections of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation Using a Pre-filled Syringe in Healthy Subjects
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.
formulations of ixekizumab using a prefilled syringe. Information about any side effects
(including injection site reactions [ISRs]) will be collected.
Inclusion Criteria:
- 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 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
- 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
We found this trial at
2
sites
Madison, Wisconsin 53704
Principal Investigator: Nicholas Siebers
Phone: 608-442-8200
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