Healthy
Conditions
Brief summary
The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo (dummy drug). The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- Have venous access sufficient to allow for blood sampling and administration of investigational product
Exclusion criteria
* Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per 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 receive during the study * Must not be immunocompromised * Must not have known hypersensitivity to hyaluronidases * 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 dosing * Must not have significant allergies to humanized monoclonal antibodies * Must not have clinically significant multiple or severe drug allergies, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | Within 1-minute post injection | The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain). |
Countries
United Kingdom
Outcome results
None listed