A Study of Two Formulations of LY3074828 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/21/2019 |
| Start Date: | September 6, 2018 |
| End Date: | January 25, 2019 |
A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 2-mL Autoinjector in Healthy Subjects
The purpose of this study is to look at the amount of the study drug, LY3074828, that gets
into the blood stream and how long it takes the body to get rid of LY3074828 when given as
different formulations. The tolerability of LY3074828 will also be evaluated and information
about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant,
the study will last about 12 weeks, not including screening.
into the blood stream and how long it takes the body to get rid of LY3074828 when given as
different formulations. The tolerability of LY3074828 will also be evaluated and information
about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant,
the study will last about 12 weeks, not including screening.
Inclusion Criteria:
Exclusion Criteria:
- Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and
14 units/week (females)
- Must not show evidence of active or latent tuberculosis (TB)
- Must not have received live vaccine(s) (including attenuated live vaccines and those
administered intranasally) within 8 weeks of screening, or intend to during the study
- Must not have been treated with steroids within 1 month of screening, or intend to
during the study
- Must not be immunocompromised
- Must not have received treatment with biologic agents (e.g. monoclonal antibodies,
including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior
to Day 1
- Must not have significant allergies to humanised monoclonal antibodies
- Must not have clinically significant multiple or severe drug allergies, or intolerance
to topical corticosteroids, or severe post treatment hypersensitivity reactions
- Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except
for basal cell or squamous epithelial carcinomas of the skin that have been resected
with no evidence of metastatic disease for 3 years
- Must not have had breast cancer within the past 10 years
We found this trial at
1
site
Daytona Beach, Florida 32117
Principal Investigator: Hugh A Coleman
Phone: 386-257-5717
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