A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Healthy Clinical Trial

Official title:

A Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533411
• Other study ID #: 18244
• Secondary ID: I5T-MC-AACK
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: February 15, 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Donanemab
Administered IV.
• Placebo
Administered IV.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Day 85
Secondary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab	PK: Cmax of Donanemab	Predose on Day 1 up to Day 85
Secondary	PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of Donanemab	PK: AUC[0-8] of Donanemab	Predose on Day 1 up to Day 85