A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 52
- Locations
- 1
- 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
Overview
Brief Summary
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.
The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At the time of initial screening, in general good health
- •First-generation healthy Japanese (age 20 to 65 years) will be included
Exclusion Criteria
- •Pregnancy or breastfeeding during the study
- •Chronic infection
- •Treatment with prohibited medications
Arms & Interventions
LY3200327 (IV)
Single intravenous (IV) dose of LY3200327
Intervention: LY3200327 (IV) (Drug)
Placebo (SC)
Single subcutaneous (SC) dose of placebo
Intervention: Placebo (SC) (Drug)
LY3200327 (SC)
Single escalating subcutaneous (SC) dose of LY3200327
Intervention: LY3200327 (SC) (Drug)
Placebo (IV)
Single intravenous (IV) dose of placebo
Intervention: Placebo (IV) (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: Baseline to study completion (approximately 12 weeks)
Secondary Outcomes
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327(Pre-dose up to 84 days post dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327(Pre-dose up to 84 days post dose)