A Study of Donanemab (LY3002813) in Healthy Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-04

Study Completion Date

2023-07-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

NCT05269004

Multiple Sclerosis

ACTIVE_NOT_RECRUITING PHASE3

Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design

NCT01945359

Relapsing Remitting Multiple Sclerosis

COMPLETED

Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

NCT00262314

Multiple Sclerosis

COMPLETED

Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

NCT02688985

Relapsing Multiple Sclerorsis Multiple Sclerosis, Primary Progressive

COMPLETED PHASE3

Safety Study of BIIB033 in Subjects With Multiple Sclerosis

NCT01244139

Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Donanemab

Intervention Type DRUG

Administered IV.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Donanemab

Administered IV.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3002813

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants who are overtly healthy as determined by medical evaluation
* Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.
* Females of childbearing potential will be excluded from the study.

Exclusion Criteria

* Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Have a history within the past 5 years of a primary or recurrent malignant disease
* Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing
* Are pregnant or intend to become pregnant or to breastfeed during the study
* Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions
* Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes