A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- The Number of Participants with One or More Drug-Related Adverse Events
Overview
Brief Summary
The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.
Protocol amended in January, 2016 to include first generation Japanese participants.
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
- •Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
- •Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10\^3/microliter (uL), inclusive.
- •First-generation Japanese:
- •Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
- •Are 20 to 65 years of age, inclusive, at the time of initial screening.
Exclusion Criteria
- •Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
Arms & Interventions
LY3041658 (IV)
Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.
Intervention: LY3041658 (IV) (Drug)
LY3041658 (SC)
Single dose of LY3041658 administered subcutaneously (SC).
Intervention: LY3041658 (SC) (Drug)
Placebo
Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The Number of Participants with One or More Drug-Related Adverse Events
Time Frame: Baseline to study completion (Day 85)
Secondary Outcomes
- Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658(Predose through Day 85, at specified timepoints)
- Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast)(Predose through Day 85, at specified timepoints)