- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346495
A Study of Remternetug (LY3372993) in Healthy Chinese Participants
April 17, 2026 updated by: Eli Lilly and Company
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Remternetug in Healthy Chinese Participants
The study will evaluate the safety and tolerability of remternetug when given subcutaneously (SC) (under the skin) to healthy Chinese participants.
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
The study will last up to 25 weeks, including screening period.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100053
- Xuanwu Hospital Capital Medical University
-
Xuhui District, China, 20031
- Shanghai Xuhui Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiogram (ECG), and Magnetic resonance imaging (MRI).
- Participants must be native Chinese. To qualify as Chinese for this study, the participant, the participant's biological parents, and all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- Have clinical laboratory test results within normal reference ranges for the population or study site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
- Have a body mass index within the range 18.0 to 28.0 kilograms per square meter (kg/m²), inclusive.
- Are individuals Assigned Male at Birth (AMAB) or individuals Assigned Female at Birth (AFAB) who are individuals not of childbearing potential (INOCBP). Individual of childbearing potential (IOCBP) are excluded from the trial.
Exclusion Criteria:
- Are women who are lactating.
- Have known allergies to remternetug, related compounds, including donanemab, or any components of the formulation.
- Have history of allergies to medications for the emergency treatment of systemic hypersensitivity reactions, including anaphylaxis or infusion reactions (for example, epinephrine, diphenhydramine).
- Have a 12-lead ECG abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
- Have an abnormal blood pressure or pulse rate as determined by the investigator, or a preexisting history of hypertension.
- Have a history or presence of significant psychiatric disorders.
- Have a brain MRI that demonstrates any clinically significant findings that in the opinion of the investigator may impact the participant's ability to safely participate in the study.
- Have a family history of early onset Alzheimer's disease (AD) (AD diagnosed prior to 65 years of age).
- Have a history or presence of clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions, including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis.
- Have history or presence of uncontrolled asthma, significant autoimmune disease, hereditary angioedema, or known history of common variable immune deficiency.
- Have a history or presence of serious or unstable illnesses including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, immunologic, hematologic disease, or neurological disorders and other conditions that, in the investigator's opinion, could significantly alter the absorption, metabolism, or elimination of drugs; interfere with the analyses in this study; increase risk for study intervention administration; or result in a participant's life expectancy of less than 24 months.
- Have significant neurological disease affecting the central nervous system that may affect the participant's ability to complete the study, including but not limited to dementias, serious infection of the brain, Parkinson's disease, multiple concussions, intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, stroke, unprovoked seizure, epilepsy, or recurrent seizures (except febrile childhood seizures).
- Have donated blood of more than 400 milliliter (mL) within the previous 4 weeks of study screening, or plan for blood donation during the study period.
- Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have had significant medical history of dizziness, syncope, or vasovagal attacks within the past 3 years.
- Have used or intend to use over-the-counter, prescription, or Chinese traditional medicines and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to dosing. Vitamins and mineral supplements not providing more than 100% of the recommended daily amount and thyroid hormone replacement are allowed.
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies.
- Have a positive Hepatitis C virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV ribonucleic acid (RNA) test is negative.
- Show evidence of hepatitis B or positive hepatitis B surface antigen. Other Exclusion Criteria
- Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females; 1 unit = 12 ounce (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits.
- Are unwilling to stop alcohol consumption for 48 hours prior to admission to the study site or outpatient visits.
- Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes, are unwilling to refrain from smoking for approximately 1 hour prior to each ECG and vital sign measurement during the study, or are unable to abide by CRU smoking restrictions.
- Have Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) greater than or equal to 1.5× Upper Limit of Normal (ULN) at screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Remternetug
Remternetug will be administered subcutaneously (SC)
|
Administered SC
Other Names:
|
|
Placebo Comparator: Placebo
Placebo will be administered Subcutaneously (SC)
|
Administered SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline through study completion up to 25 weeks
|
Baseline through study completion up to 25 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Remternetug
Time Frame: Day 1 through Day 5
|
Day 1 through Day 5
|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of Remternetug
Time Frame: Day 1 through Day 5
|
Day 1 through Day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
January 9, 2026
First Submitted That Met QC Criteria
January 9, 2026
First Posted (Actual)
January 16, 2026
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 18470
- J1G-GH-LAKE (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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