A Study of Donanemab (LY3002813) in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Donanemab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05567159

I5T-MC-AACP (Other Identifier)

18616

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Donanemab

Experimental group

Description:

Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.

Treatment:

Drug: Donanemab