A Study of Donanemab (LY3002813) in Healthy Participants

NCT05567159 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18616I5T-MC-AACP
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  As per the prespecified analysis, AUC\[0-4 weeks\] will be calculated as the sum of AUC0-2weeks for: * treatment period 1 and 2 (dosing days 1, 15 respectively) represented as period 2 * treatment period 3 and 4 (dosing days 29, 43 respectively) represented as period 4 * treatment period 5 and 6 (dosing days 57, 71 respectively) represented as period 6.

  Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71

• PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab

  PK: Cmax, ss of Donanemab

  Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71

• PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab

  PK: AUCτ,ss of Donanemab

  Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71

Study Arms (1)

Donanemab

EXPERIMENTAL

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.

Drug: Donanemab

Interventions

Donanemab DRUG

Administered IV.

Also known as: LY3002813

Donanemab

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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ICON Early Phase Services Lenexa Center

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

donanemab

Results Point of Contact

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

ClinicalTrials.gov@lilly.com

800- 545-5979

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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: October 4, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: October 4, 2024
• Results First Posted: October 4, 2024

Record last verified: 2024-07-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)