A Study of Donanemab (LY3002813) in Healthy Participants

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Donanemab	Donanemab	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.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.	Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71	As per the prespecified analysis, AUC\[0-4 weeks\] will be calculated as the sum of AUC0-2weeks for: * treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2 * treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4 * treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.
PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab	Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71	PK: Cmax, ss of Donanemab
PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab	Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71	PK: AUCτ,ss of Donanemab