A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Donanemab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05533411

I5T-MC-AACK (Other Identifier)

18244

Details and patient eligibility

About

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.

Enrollment: 36 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
• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

350 milligram (mg) Donanemab

Experimental group

Description:

Single 350 mg Donanemab dose administered intravenously (IV) on Day 1.

Treatment:

Drug: Donanemab

700 mg Donanemab

Experimental group

Description:

Single 700 mg Donanemab dose administered IV on Day 1.

Treatment:

Drug: Donanemab

1400 mg Donanemab

Experimental group

Description:

Single 1400 mg Donanemab dose administered IV on Day 1.

Treatment:

Drug: Donanemab

Placebo

Placebo Comparator group

Description:

Single placebo dose administered IV on Day 1.

Treatment:

Drug: Placebo