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.
|Study Design:||Allocation: Randomized|
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
|Official Title:||A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases|
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Dosing Day 1 through Day 127 ]
Secondary Outcome Measures:
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658 [ Time Frame: 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 [ Time Frame: Dosing Day 1 through Day 127 ]
- Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658 [ Time Frame: Dosing Day 1 through Day 127 ]
|Actual Study Start Date:||November 8, 2016|
|Estimated Study Completion Date:||February 2019|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
| Experimental: LY3041658|
LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
| Drug: LY3041658|
| Placebo Comparator: Placebo|
Placebo administered IV once every two weeks over 6 weeks (four doses).
| Drug: Placebo|