HealthyPhase 1NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

A Phase 1 study testing Donanemab in people with Healthy, run by Eli Lilly and Company at 2 sites in China.

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 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. 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?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 2 sitesChina
Study dates: 14 Sep 2022to 5 Jan 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
Participants are native Chinese participants. To qualify as a native Chinese, the participant, the participant's biological parents, and all four of the participant's biological grandparents must be of Chinese origin.
Have a body mass index (BMI) of 18.0 and 28.0, kilograms per meter squared (kg/m²), inclusive.

Who cannot join

Are lactating.
Are women of childbearing potential.
Have known allergies to donanemab, related compounds or any components of the formulation or history of significant atopy.
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within three months or five half-lives (whichever is longer) prior to dosing.
Have participated, within the last 30 days, in a clinical study involving an investigational product; at least five half-lives or 30 days (whichever is longer) should have passed.
Have history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, stroke or epilepsy.
Participants who show evidence of positive HIV antibodies, or positive hepatitis C antibody, or positive hepatitis B surface antigen
Have had leukemia, lymphoma, or any malignancy within the past five years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for three years. Have had breast cancer within the past 10 years.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Peking University First Hospital
Beijing, Beijing Municipality, 100034
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013

Other trials in China

About this study

Official title: A Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese Participants

Conditions: Healthy
Being tested: Donanemab, Placebo

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.
PlaceboDrug
Administered IV.

Study groups in NCT05533411
Study group	Role	What they receive
350 milligram (mg) Donanemab	Experimental	Single 350 mg Donanemab dose administered intravenously (IV) on Day 1. Receives: Drug: Donanemab
700 mg Donanemab	Experimental	Single 700 mg Donanemab dose administered IV on Day 1. Receives: Drug: Donanemab
1400 mg Donanemab	Experimental	Single 1400 mg Donanemab dose administered IV on Day 1. Receives: Drug: Donanemab
Placebo	Placebo comparator	Single placebo dose administered IV on Day 1. Receives: Drug: Placebo

What is being measured

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

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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.
Measured: Baseline up to Day 85

Secondary outcomes (2)

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab
PK: Cmax of Donanemab
Measured: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab
PK: AUC[0-∞] of Donanemab
Measured: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose

Timeline

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

14 Sep 20225 Jan 2023

First posted9 Sep 2022
Study start14 Sep 2022
Primary completion5 Jan 2023
Study completion5 Jan 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05533411
Sponsor's protocol ID: 18244
Other IDs: I5T-MC-AACK
Status last verified: Jul 2024
First submitted: 6 Sep 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 Parallel-group Treatment, Phase 1, Participant- and Investigator-Blind, Randomized Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Dose of Donanemab Compared With Placebo in Healthy Chinese Participants
ClinicalTrials.gov ID: NCT05533411
Acronym / sponsor ID: 18244
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 14 Sep 2022 (actual)
Primary completion: 5 Jan 2023 (actual)
Study completion: 5 Jan 2023 (actual)
First posted: 9 Sep 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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
350 milligram (mg) Donanemab	Experimental	Drug: DonanemabSingle 350 mg Donanemab dose administered intravenously (IV) on Day 1.
700 mg Donanemab	Experimental	Drug: DonanemabSingle 700 mg Donanemab dose administered IV on Day 1.
1400 mg Donanemab	Experimental	Drug: DonanemabSingle 1400 mg Donanemab dose administered IV on Day 1.
Placebo	Placebo comparator	Drug: PlaceboSingle placebo dose administered IV on Day 1.

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
Participants are native Chinese participants. To qualify as a native Chinese, the participant, the participant's biological parents, and all four of the participant's biological grandparents must be of Chinese origin.
Have a body mass index (BMI) of 18.0 and 28.0, kilograms per meter squared (kg/m²), inclusive.

Key exclusion criteria (8 listed)

Are lactating.
Are women of childbearing potential.
Have known allergies to donanemab, related compounds or any components of the formulation or history of significant atopy.
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within three months or five half-lives (whichever is longer) prior to dosing.
Have participated, within the last 30 days, in a clinical study involving an investigational product; at least five half-lives or 30 days (whichever is longer) should have passed.

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	1400 mg Donanemab, 350 milligram (mg) Donanemab, 700 mg Donanemab
PlaceboAdministered IV.	Drug	Placebo

Primary outcome

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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.

2 secondary outcomes

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab
Time frame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab
Time frame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose

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
Placebo	6	6
350 Milligram (mg) Donanemab	10	10
700 mg Donanemab	10	10
1400 mg Donanemab	10	10

Primary outcome: 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. Number. Unit: participants

Measure	Placebo n = 6	350 mg Donanemab n = 10	700 mg Donanemab n = 10	1400 mg Donanemab n = 10
Treatment-emergent Adverse Events	1	2	0	0
Serious Adverse Events	0	0	0	0

Population analysed: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 85 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
350 Milligrams (mg) Donanemab	0 of 10 (0%)	6 of 10 (60%)	0 of 10
700 mg Donanemab	0 of 10 (0%)	4 of 10 (40%)	0 of 10
1400 mg Donanemab	0 of 10 (0%)	5 of 10 (50%)	0 of 10

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

Related trials for Healthy

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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

2 sites 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 2 sites in China.

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 8 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 2 sites in China. 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. Some participants in this study may receive a placebo. 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?

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). 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 NCT05533411.

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.