Clinical trial NCT05533411: A Study of Donanemab (LY3002813) in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-09-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline up to Day 85
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab
timeFrame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab
timeFrame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: