A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Phase 1

Completed

Brief Summary: The main purpose of this study is to evaluate the safety and tolerability of donanemab (LY3002813) when administered as single dose in healthy Chinese participants. The study will also assess how fast donanemab gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 85 days.

Recruitment & Eligibility

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation
Participants are native Chinese participants. To qualify as a native Chinese, the participant, the participant's biological parents, and all four of the participant's biological grandparents must be of Chinese origin.
Have a body mass index (BMI) of 18.0 and 28.0, kilograms per meter squared (kg/m²), inclusive.

Exclusion Criteria

Are lactating.
Are women of childbearing potential.
Have known allergies to donanemab, related compounds or any components of the formulation or history of significant atopy.
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within three months or five half-lives (whichever is longer) prior to dosing.
Have participated, within the last 30 days, in a clinical study involving an investigational product; at least five half-lives or 30 days (whichever is longer) should have passed.
Have history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, stroke or epilepsy.
Participants who show evidence of positive HIV antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen
Have had leukemia, lymphoma, or any malignancy within the past five years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for three years. Have had breast cancer within the past 10 years.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single placebo dose administered IV on Day 1.
350 milligram (mg) Donanemab	Donanemab	Single 350 mg Donanemab dose administered intravenously (IV) on Day 1.
700 mg Donanemab	Donanemab	Single 700 mg Donanemab dose administered IV on Day 1.
1400 mg Donanemab	Donanemab	Single 1400 mg Donanemab dose administered IV on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Day 85	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab	Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose	PK: Cmax of Donanemab
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab	Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose	PK: AUC\[0-∞\] of Donanemab

Locations (2): The Third Xiangya Hospital of Central South University
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Changsha, Hunan, China
Peking University First Hospital
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Beijing, Beijing, China