A Study of Donanemab (LY3002813) in Healthy Participants

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Eli Lilly and Company
Study ID
NCT05567159
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.

Key Dates

Start date
Oct 4, 2022
Status verified
Jul 2024
Primary completion
Jul 14, 2023
Completion
Jul 14, 2023

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Donanemab
    Participants received a 350 milligrams (mg) intravenous (IV) infusion of donanemab every two weeks for six treatment periods (1 to 6), each lasting two weeks. Treatments were administered on the first day of each period, i.e., days 1, 15, 29, 43, 57, and 71.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6. [ Time Frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71 ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON Early Phase Services Lenexa CenterSalt Lake CityUtah84124-

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ICON Early Phase Services Lenexa Center· Salt Lake City, UT

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