NCT05533411

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Completed Phase 1 Results posted Last updated 4 October 2024

What this trial tests

Phase 1 trial testing Donanemab in Healthy in 36 participants. Completed in 5 January 2023.

Timeline

14 September 2022

Primary endpoint
5 January 2023

5 January 2023

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	36
Start date	14 September 2022
Primary completion	5 January 2023
Estimated completion	5 January 2023
Sites	2 locations across China

Drugs / interventions tested

• Donanemab (DONANEMAB) — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 40, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Treatment-emergent Adverse Events

Group	Value	95% CI
Placebo	1
350 mg Donanemab	2
700 mg Donanemab	0
1400 mg Donanemab	0

Serious Adverse Events

Group	Value	95% CI
Placebo	0
350 mg Donanemab	0
700 mg Donanemab	0
1400 mg Donanemab	0

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab Secondary · Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose

PK: Cmax of Donanemab

Group	Value	95% CI
350 mg Donanemab	119	± 13
700 mg Donanemab	236	± 9
1400 mg Donanemab	539	± 30

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

PK: AUC\[0-∞\] of Donanemab

Group	Value	95% CI
350 mg Donanemab	9050	± 23
700 mg Donanemab	22600	± 17
1400 mg Donanemab	53100	± 27

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 85 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/6 (0%)

Deaths: 0/6

350 Milligrams (mg) Donanemab

Serious: 0/10 (0%)

Deaths: 0/10

700 mg Donanemab

Serious: 0/10 (0%)

Deaths: 0/10

1400 mg Donanemab

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (16 terms — click to expand)

Reaction	System	Placebo	350 Milligrams (mg) Donane…	700 mg Donanemab	1400 mg Donanemab
Asymptomatic COVID-19	Infections and infestations	—	—	—	—
Blood uric acid increased	Investigations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Allergy to arthropod bite	Immune system disorders	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—
Blood urea increased	Investigations	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—
Neutrophil count increased	Investigations	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT05533411 adverse events section.

Sponsor's own description

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. The study is open to healthy participants. The study will last up to approximately 85 days.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The FDA-approved anti-amyloid-β monoclonal antibodies for the treatment of Alzheimer's disease: a systematic review and meta-analysis of randomized controlled trials.
   Wu W, Ji Y, Wang Z, Wu X, et al · · 2023 · cited 81× · PMID 38017568 · DOI 10.1186/s40001-023-01512-w
2. Gut Microbiota and Immunotherapy for Alzheimer's Disease.
   Dai CL, Liu F, Iqbal K, Gong CX. · · 2022 · cited 13× · PMID 36499564 · DOI 10.3390/ijms232315230