A Study of LY3074828 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/19/2018 |
| Start Date: | March 6, 2018 |
| End Date: | August 13, 2018 |
A Safety, Tolerability, and Pharmacokinetic Study of 1- and 2-mL Injections of LY3074828 Solution Using Investigational Pre-filled Syringes and Investigational Autoinjectors 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 a
solution formulation in different devices. 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 total duration of the clinical trial will be approximately 13 weeks, not including
screening.
into the blood stream and how long it takes the body to get rid of LY3074828, when given as a
solution formulation in different devices. 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 total duration of the clinical trial will be approximately 13 weeks, not including
screening.
Inclusion Criteria:
- Must be healthy male or female
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 1 month 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 sever 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
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