Healthy
Conditions
Brief 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. The study is open to healthy participants. The study will last up to approximately 85 days.
Interventions
DRUGDonanemab
Administered IV.
DRUGPlacebo
Administered IV.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab | Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose | PK: Cmax of Donanemab |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab | Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose | PK: AUC\[0-∞\] of Donanemab |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Single placebo dose administered IV on Day 1. | 6 |
| 350 mg Donanemab Single 350 mg Donanemab dose administered IV on Day 1. | 10 |
| 700 mg Donanemab Single 700 mg Donanemab dose administered IV on Day 1. | 10 |
| 1400 mg Donanemab Single 1400 mg Donanemab dose administered IV on Day 1. | 10 |
| Total | 36 |
Baseline characteristics
| Characteristic | Placebo | Total | 1400 mg Donanemab | 700 mg Donanemab | 350 mg Donanemab |
|---|---|---|---|---|---|
| Age, Continuous | 27.0 years STANDARD_DEVIATION 7 | 29.2 years STANDARD_DEVIATION 6 | 27.9 years STANDARD_DEVIATION 5.8 | 32.8 years STANDARD_DEVIATION 4.5 | 28.1 years STANDARD_DEVIATION 6.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 36 Participants | 10 Participants | 10 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 6 Participants | 36 Participants | 10 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 36 Participants | 10 Participants | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 5 / 6 | 6 / 10 | 4 / 10 | 5 / 10 |
| serious Total, serious adverse events | 0 / 6 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Baseline up to Day 85
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Treatment-emergent Adverse Events | 1 participants |
| Placebo | 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 | Serious Adverse Events | 0 participants |
| 350 mg Donanemab | 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 | Serious Adverse Events | 0 participants |
| 350 mg Donanemab | 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 | Treatment-emergent Adverse Events | 2 participants |
| 700 mg Donanemab | 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 | Treatment-emergent Adverse Events | 0 participants |
| 700 mg Donanemab | 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 | Serious Adverse Events | 0 participants |
| 1400 mg Donanemab | 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 | Treatment-emergent Adverse Events | 0 participants |
| 1400 mg Donanemab | 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 | Serious Adverse Events | 0 participants |
Secondary
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab
PK: Cmax of Donanemab
Time frame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
Population: All enrolled participants who received at least 1 full dose of donanemab and had baseline, and at least 1 postbaseline evaluable PK sample.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab | 119 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 13 |
| 350 mg Donanemab | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab | 236 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 9 |
| 700 mg Donanemab | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab | 539 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 30 |
Secondary
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab
PK: AUC\[0-∞\] of Donanemab
Time frame: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose
Population: All enrolled participants who received at least 1 full dose of donanemab and had baseline, and at least 1 postbaseline evaluable PK sample.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab | 9050 microgram * hour/milliliter (μg.h/mL) | Geometric Coefficient of Variation 23 |
| 350 mg Donanemab | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab | 22600 microgram * hour/milliliter (μg.h/mL) | Geometric Coefficient of Variation 17 |
| 700 mg Donanemab | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab | 53100 microgram * hour/milliliter (μg.h/mL) | Geometric Coefficient of Variation 27 |