A Study of Donanemab (LY3002813) in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2023-04-20
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation

• Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.

• Females of childbearing potential will be excluded from the study.

Exclusion Criteria:

• Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone

• Have a history within the past 5 years of a primary or recurrent malignant disease

• Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing

• Are pregnant or intend to become pregnant or to breastfeed during the study

• Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions

• Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome