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| ID | Type | Description | Link |
|---|---|---|---|
| I5T-MC-AACK | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 350 milligram (mg) Donanemab | Experimental | Single 350 mg Donanemab dose administered intravenously (IV) on Day 1. |
|
| 700 mg Donanemab | Experimental | Single 700 mg Donanemab dose administered IV on Day 1. |
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| 1400 mg Donanemab | Experimental | Single 1400 mg Donanemab dose administered IV on Day 1. |
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| Placebo | Placebo Comparator | Single placebo dose administered IV on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donanemab | Drug | Administered IV. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab | PK: Cmax of Donanemab | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| The Third Xiangya Hospital of Central South University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single placebo dose administered intravenously (IV) on Day 1. |
| FG001 | 350 Milligram (mg) Donanemab | Single 350 mg Donanemab dose administered IV on Day 1. |
| FG002 | 700 mg Donanemab | Single 700 mg Donanemab dose administered IV on Day 1. |
| FG003 | 1400 mg Donanemab | Single 1400 mg Donanemab dose administered IV on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single placebo dose administered IV on Day 1. |
| BG001 | 350 mg Donanemab | Single 350 mg Donanemab dose administered IV on Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Number | participants | Baseline up to Day 85 |
|
Baseline up to 85 days
All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single placebo dose administered intravenously (IV) on Day 1. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy to arthropod bite | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005955979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2022 | Sep 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2022 | Sep 5, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729112 | donanemab |
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| Placebo | Drug | Administered IV. |
|
PK: AUC[0-∞] of Donanemab |
| Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose |
| Changsha |
| Hunan |
| 410013 |
| China |
| BG002 | 700 mg Donanemab | Single 700 mg Donanemab dose administered IV on Day 1. |
| BG003 | 1400 mg Donanemab | Single 1400 mg Donanemab dose administered IV on Day 1. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 350 mg Donanemab |
Single 350 mg Donanemab dose administered IV on Day 1. |
| OG002 | 700 mg Donanemab | Single 700 mg Donanemab dose administered IV on Day 1. |
| OG003 | 1400 mg Donanemab | Single 1400 mg Donanemab dose administered IV on Day 1. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab | PK: Cmax of Donanemab | All enrolled participants who received at least 1 full dose of donanemab and had baseline, and at least 1 postbaseline evaluable PK sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose |
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|
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| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab | PK: AUC[0-∞] of Donanemab | All enrolled participants who received at least 1 full dose of donanemab and had baseline, and at least 1 postbaseline evaluable PK sample. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | microgram * hour/milliliter (μg.h/mL) | Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose |
|
|
|
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | 350 Milligrams (mg) Donanemab | Single 350 mg Donanemab dose administered IV on Day 1. | 0 | 10 | 0 | 10 | 6 | 10 |
| EG002 | 700 mg Donanemab | Single 700 mg Donanemab dose administered IV on Day 1. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG003 | 1400 mg Donanemab | Single 1400 mg Donanemab dose administered IV on Day 1. | 0 | 10 | 0 | 10 | 5 | 10 |
| Asymptomatic COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Neutrophil count increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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