A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Sponsor
Eli Lilly and Company
Study ID
NCT05533411
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Donanemab — DRUG
    Administered IV.
  • Placebo — DRUG
    Administered IV.

Study Details

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.

Key Dates

Start date
Sep 14, 2022
Status verified
Jul 2024
Primary completion
Jan 5, 2023
Completion
Jan 5, 2023

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 350 milligram (mg) Donanemab
    Single 350 mg Donanemab dose administered intravenously (IV) on Day 1.
  • Experimental: 700 mg Donanemab
    Single 700 mg Donanemab dose administered IV on Day 1.
  • Experimental: 1400 mg Donanemab
    Single 1400 mg Donanemab dose administered IV on Day 1.
  • Placebo Comparator: Placebo
    Single placebo dose administered IV on Day 1.

Primary Outcome 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 [ Time Frame: Baseline up to Day 85 ]

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