Psoriasis, Skin Diseases
Conditions
Brief summary
The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.
Interventions
DRUGLY3041658
Administered IV.
DRUGPlacebo
Administered IV.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Investigator confirmed diagnosis of certain skin diseases for at least 6 months. * Active skin lesions that are not responding to standard therapies. * Willing to undergo pre- and post-treatment skin biopsies of lesions.
Exclusion criteria
\- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Dosing Day 1 through Day 127 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 | Dosing Day 1 through Day 127 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658 | Dosing Day 1 through Day 127 |
| Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658 | Dosing Day 1 through Day 127 |
Countries
United States
Outcome results
None listed