A Study of Donanemab (LY3002813) in Healthy Chinese Participants

NCT05533411 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18244I5T-MC-AACK
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Baseline up to Day 85

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab

  Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose

• 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

Study Arms (4)

350 milligram (mg) Donanemab

EXPERIMENTAL

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

Drug: Donanemab

700 mg Donanemab

EXPERIMENTAL

Single 700 mg Donanemab dose administered IV on Day 1.

Drug: Donanemab

1400 mg Donanemab

EXPERIMENTAL

Single 1400 mg Donanemab dose administered IV on Day 1.

Drug: Donanemab

Placebo

PLACEBO COMPARATOR

Single placebo dose administered IV on Day 1.

Drug: Placebo

Interventions

Donanemab DRUG

Administered IV.

Also known as: LY3002813

1400 mg Donanemab; 350 milligram (mg) Donanemab; 700 mg Donanemab

Placebo DRUG

Administered IV.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

MeSH Terms

Interventions

donanemab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

8005955979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: September 14, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)