A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
LY3041658
LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).
Intervention: LY3041658 (Drug)
Placebo
Placebo administered IV once every two weeks over 6 weeks (four doses).
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)