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Completed

NCT Number: NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Donanemab

Drug

Administered IV.

Other names: LY3002813

Placebo

Drug

Administered IV.

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

    Time frame: Baseline up to Day 85

    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.

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab

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

    PK: Cmax of Donanemab

  2. PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab

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

    PK: AUC[0-∞] of Donanemab

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2022
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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