A Study of Ixekizumab in Healthy Participants
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/21/2019 |
| Start Date: | January 29, 2019 |
| End Date: | May 26, 2019 |
Relative Bioavailability of 2 Ixekizumab Test Formulations Compared to the Commercial Formulation in Healthy Subjects
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 and Test 2) have not been approved. This study will compare how much of
each of the three formulations get into the blood stream. Information about any side effects
that may occur will also be collected.
formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two
formulations (Test 1 and Test 2) have not been approved. This study will compare how much of
each of the three formulations get into the blood stream. Information about any side effects
that may occur will also be collected.
Inclusion Criteria:
- 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 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, if
participating in the study
We found this trial at
1
site
Daytona Beach, Florida 32117
Principal Investigator: Lawrence A Galitz
Phone: 386-366-6400
Click here to add this to my saved trials
