HealthyPhase 1NCT05567159

A Study of Donanemab (LY3002813) in Healthy Participants

A Phase 1 study testing Donanemab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Donanemab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2022to 14 Jul 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

ICON Early Phase Services Lenexa Center
Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants

Conditions: Healthy
Being tested: Donanemab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DonanemabDrug
Also called LY3002813
Administered IV.

Study groups in NCT05567159
Study group	Role	What they receive
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. Receives: Drug: Donanemab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 202214 Jul 2023

First posted5 Oct 2022
Study start4 Oct 2022
Primary completion14 Jul 2023
Study completion14 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05567159
Sponsor's protocol ID: 18616
Other IDs: I5T-MC-AACP
Status last verified: 1 Jul 2024
First submitted: 3 Oct 2022
Last updated: 4 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants
ClinicalTrials.gov ID: NCT05567159
Acronym / sponsor ID: 18616
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 4 Oct 2022 (actual)
Primary completion: 14 Jul 2023 (actual)
Study completion: 14 Jul 2023 (actual)
First posted: 5 Oct 2022 (actual)
Results: Posted 4 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Donanemab	Experimental	Drug: DonanemabParticipants 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DonanemabAlso: LY3002813Administered IV.	Drug	Donanemab

Primary outcome

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
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.
PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab
Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
PK: Cmax, ss of Donanemab
PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab
Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
PK: AUCτ,ss of Donanemab

Results and safety

Results posted to the registry on 4 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Donanemab	42	34

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: microgram*hour per milliliter (μg*h/mL)

Measure	Donanemab n = 27
Period 2	17300 (23)
Period 4	15400 (32)
Period 6	15500 (45)

Population analysed: All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.

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

Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71. Geometric mean (Geometric Coefficient of Variation). Unit: μg/mL

Measure	Donanemab n = 27
Value	112 (21)

Population analysed: All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.

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

Time frame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71. Geometric mean (Geometric Coefficient of Variation). Unit: μg*h/mL

Measure	Donanemab n = 27
Value	7590 (50)

Population analysed: All enrolled participants who received at least one IV infusion of donanemab and had evaluable PK data.

Adverse events

Time frame: Baseline to Week 22. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Donanemab	0 of 42 (0%)	22 of 42 (52.4%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Donanemab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.