NCT02754830

A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)

Single-Dose, Dose-Escalation Study With LY3303560 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin. Screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for AD participants. The study requires about 16 weeks of each participant's time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments. This is the first time that this study drug is being given to participants. This study is for research purposes only, and is not intended to treat any medical condition.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	LY3303560 - IV	Administered IV
DRUG	Saline Solution - IV	Administered IV
DRUG	LY3303560 - SC	Administered SC

Timeline

• Start date: 2016-04-25
• Primary completion: 2018-07-10
• Completion: 2018-07-10
• First posted: 2016-04-28
• Last updated: 2023-10-13
• Results posted: 2023-09-21

Locations

2 sites across 1 country: United States