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

Lilly

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: LY3303560 - IV; Drug: LY3303560 - SC; Drug: Saline Solution - IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02754830

I8G-MC-LMDA (Other Identifier)

16120

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy males or females of non-childbearing potential and who have given consent and are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• AD participants must be at least 50 years of age and have diagnostic criteria consistent with either mild cognitive impairment due to AD or mild-to moderate AD and have a positive florbetapir positron emission tomography (PET) scan

Exclusion criteria

• Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy
• Have an increased risk of seizures
• For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by magnetic resonance imaging (MRI)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 3 patient groups, including a placebo group

LY3303560

Experimental group

Description:

Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants.

Treatment:

Drug: LY3303560 - IV

Saline Solution

Placebo Comparator group

Description:

Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants.

Treatment:

Drug: Saline Solution - IV

LY3303560 Subcutaneous (SC)

Experimental group

Description:

Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants.

Treatment:

Drug: LY3303560 - SC