Alzheimer Disease
Conditions
Brief summary
The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. The study involves 3 parts. * Part A in which participants will receive a single dose of LY3002813 or placebo (no drug). * Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks. * Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks. Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.
Interventions
BIOLOGICALLY3002813
Administered IV
DRUGPlacebo
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD * Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year * Have up to 2 partners who will provide a separate written informed consent to participate * Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator * Positive florbetapir scan
Exclusion criteria
* Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications * Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study * History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy * Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker * Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone * Have gamma globulin therapy within the last year * Previously dosed in any other study investigating active immunization against amyloid beta (Aβ) * Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months * Have current serious or unstable illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | Baseline, Week 72 | Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C | Predose, end of infusion, 3, 24, 48 and 72 hours postdose | Area under the concentration versus time curve during one dosing interval at day 1 was reported. |
| PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C | Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose | AUCtau of LY3002813 at steady state (Day 127 \[10 mg/kg Q2W\] for part B and Day 141 \[10 mg/kg and 20 mg/kg Q4W\]) for Part C following multiple dose administration of LY3002813 was evaluated. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A | Predose, end of infusion, 3, 24 and 48 hours postdose | Area under the curve from time zero to last quantifiable concentration \[AUC (0-tlast)\] at day 1 was reported. |
| PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C | Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose | Cmax of LY3002813 at steady state (Day 127 \[10 mg/kg Q2W\] for part B and Day 141 \[10 mg/kg and 20 mg/kg Q4W\]) for Part C following multiple dose administration of LY3002813 was evaluated. |
| Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | Predose up to Day 589 | Blood samples were tested to determine if a participant reacted to LY3002813 by producing anti-LY3002813 antibodies. Samples were identified as TE-ADAs if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100. |
| PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose | Maximum serum concentration of LY3002813 during one dosing interval at day 1 was reported. |
Countries
Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: Placebo Single Dose (SD) Participants received single intravenous (IV) dose of placebo. | 7 |
| Part A: 10 mg/kg LY3002813 SD Participants received single IV dose of 10 mg/kg LY3002813. | 7 |
| Part A: 20 mg/kg LY3002813 SD Participants received single IV dose of 20 mg/kg LY3002813. | 7 |
| Part A: 40 mg/kg LY3002813 SD Participants received single IV dose of 40 mg/kg LY3002813. | 4 |
| Part B: Placebo Q2W Participants received multiple IV doses of placebo every 2 weeks (Q2W) for 24 weeks. | 3 |
| Part B: 10 mg/kg LY3002813 Q2W Participants received multiple IV doses of 10 mg/kg LY3002813 Q2W for 24 weeks. | 10 |
| Part C: Placebo Q4W Participants received multiple IV doses of placebo every 4 weeks (Q4W) for 72 weeks. | 5 |
| Part C:10 mg/kg LY3002813 Q4W Participants received multiple IV doses of 10 mg/kg LY3002813 Q4W for 72 weeks. | 8 |
| Part C:20 mg/kg LY3002813 Q4W Participants received multiple IV doses of 20 mg/kg LY3002813 Q4W for 72 weeks. | 10 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Part A: Placebo Single Dose (SD) | Part A: 20 mg/kg LY3002813 SD | Part A: 10 mg/kg LY3002813 SD | Part A: 40 mg/kg LY3002813 SD | Part B: Placebo Q2W | Part B: 10 mg/kg LY3002813 Q2W | Part C: Placebo Q4W | Part C:10 mg/kg LY3002813 Q4W | Part C:20 mg/kg LY3002813 Q4W | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 79.6 years STANDARD_DEVIATION 7.7 | 75.6 years STANDARD_DEVIATION 6.4 | 78.3 years STANDARD_DEVIATION 8.4 | 75.3 years STANDARD_DEVIATION 6.7 | 65.7 years STANDARD_DEVIATION 4.9 | 66.8 years STANDARD_DEVIATION 8.6 | 72.6 years STANDARD_DEVIATION 12.2 | 73.0 years STANDARD_DEVIATION 7.8 | 71.7 years STANDARD_DEVIATION 9.2 | 73.2 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 7 Participants | 4 Participants | 3 Participants | 9 Participants | 5 Participants | 8 Participants | 9 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 5 Participants | 1 Participants | 2 Participants | 7 Participants | 3 Participants | 5 Participants | 7 Participants | 40 Participants |
| Region of Enrollment Japan | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 18 Participants |
| Region of Enrollment United States | 5 Participants | 6 Participants | 5 Participants | 2 Participants | 2 Participants | 7 Participants | 3 Participants | 5 Participants | 8 Participants | 43 Participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants | 4 Participants | 6 Participants | 34 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 6 Participants | 2 Participants | 4 Participants | 4 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 | 0 / 7 | 0 / 4 | 0 / 3 | 0 / 10 | 1 / 5 | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 5 / 7 | 7 / 7 | 6 / 7 | 4 / 4 | 2 / 3 | 10 / 10 | 4 / 5 | 8 / 8 | 9 / 10 |
| serious Total, serious adverse events | 2 / 7 | 0 / 7 | 0 / 7 | 0 / 4 | 0 / 3 | 0 / 10 | 1 / 5 | 1 / 8 | 2 / 10 |
Outcome results
Primary
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr)
Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. Least square (LS) mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.
Time frame: Baseline, Week 72
Population: All randomized participants who received at least 1 dose of study drug and had baseline and post baseline scan data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A,B and C: Placebo | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.050 standard uptake value ratio (SUVr) | Standard Error 0.04 |
| Part A: 10 mg/kg LY3002813 SD | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.122 standard uptake value ratio (SUVr) | Standard Error 0.06 |
| Part A: 20 mg/kg LY3002813 SD | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.183 standard uptake value ratio (SUVr) | Standard Error 0.06 |
| Part A: 40 mg/kg LY3002813 SD | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.255 standard uptake value ratio (SUVr) | Standard Error 0.1 |
| Part B: 10 mg/kg LY3002813 Q2W | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.305 standard uptake value ratio (SUVr) | Standard Error 0.05 |
| Part C:10 mg/kg LY3002813 Q4W | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.419 standard uptake value ratio (SUVr) | Standard Error 0.06 |
| Part C:20 mg/kg LY3002813 Q4W | Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan Standard Uptake Value Ratio (SUVr) | -0.379 standard uptake value ratio (SUVr) | Standard Error 0.05 |
p-value: 0.30995% CI: [-0.21, 0.07]Mixed Models Analysis
p-value: 0.06195% CI: [-0.27, 0.01]Mixed Models Analysis
p-value: 0.05395% CI: [-0.41, 0]Mixed Models Analysis
p-value: <0.00195% CI: [-0.38, -0.13]Mixed Models Analysis
p-value: <0.00195% CI: [-0.51, -0.23]Mixed Models Analysis
p-value: <0.00195% CI: [-0.46, -0.2]Mixed Models Analysis
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A
Area under the curve from time zero to last quantifiable concentration \[AUC (0-tlast)\] at day 1 was reported.
Time frame: Predose, end of infusion, 3, 24 and 48 hours postdose
Population: All randomized participants from part A who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A,B and C: Placebo | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A | 25700 microgram*hour per milliliter(μg*hr/mL) | Geometric Coefficient of Variation 20 |
| Part A: 10 mg/kg LY3002813 SD | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A | 59400 microgram*hour per milliliter(μg*hr/mL) | Geometric Coefficient of Variation 19 |
| Part A: 20 mg/kg LY3002813 SD | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] in Part A | 110000 microgram*hour per milliliter(μg*hr/mL) | Geometric Coefficient of Variation 32 |
Secondary
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813
Blood samples were tested to determine if a participant reacted to LY3002813 by producing anti-LY3002813 antibodies. Samples were identified as TE-ADAs if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100.
Time frame: Predose up to Day 589
Population: All randomized participants who received at least one dose of study drug \& had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A,B and C: Placebo | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 13.3 percentage of participants |
| Part A: 10 mg/kg LY3002813 SD | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 85.7 percentage of participants |
| Part A: 20 mg/kg LY3002813 SD | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 100.0 percentage of participants |
| Part A: 40 mg/kg LY3002813 SD | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 100.0 percentage of participants |
| Part B: 10 mg/kg LY3002813 Q2W | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 100.0 percentage of participants |
| Part C:10 mg/kg LY3002813 Q4W | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 100.0 percentage of participants |
| Part C:20 mg/kg LY3002813 Q4W | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADAs) to LY3002813 | 100.0 percentage of participants |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C
Area under the concentration versus time curve during one dosing interval at day 1 was reported.
Time frame: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
Population: All randomized participants from part B and part C who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A,B and C: Placebo | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C | 23000 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 22 |
| Part A: 10 mg/kg LY3002813 SD | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C | 32900 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 35 |
| Part A: 20 mg/kg LY3002813 SD | Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time at a Dosing Interval (AUCtau) at Day 1 of LY3002813 in Part B and Part C | 58900 microgram*hour per milliliter (μg*hr/mL) | Geometric Coefficient of Variation 22 |
Secondary
PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C
AUCtau of LY3002813 at steady state (Day 127 \[10 mg/kg Q2W\] for part B and Day 141 \[10 mg/kg and 20 mg/kg Q4W\]) for Part C following multiple dose administration of LY3002813 was evaluated.
Time frame: Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
Population: All randomized participants from part B and part C who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A,B and C: Placebo | PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C | 29700 μg*hr/mL | Geometric Coefficient of Variation 68 |
| Part A: 10 mg/kg LY3002813 SD | PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C | 35800 μg*hr/mL | Geometric Coefficient of Variation 61 |
| Part A: 20 mg/kg LY3002813 SD | PK:Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of LY3002813 in Part B and C | 68400 μg*hr/mL | Geometric Coefficient of Variation 37 |
Secondary
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813
Maximum serum concentration of LY3002813 during one dosing interval at day 1 was reported.
Time frame: Part A: Predose, end of infusion, 3, 24 and 48 hours postdose; Part B and C: Predose, end of infusion, 3, 24, 48 and 72 hours postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A,B and C: Placebo | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | 196 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 17 |
| Part A: 10 mg/kg LY3002813 SD | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | 413 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 17 |
| Part A: 20 mg/kg LY3002813 SD | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | 910 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 15 |
| Part A: 40 mg/kg LY3002813 SD | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | 223 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 19 |
| Part B: 10 mg/kg LY3002813 Q2W | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | 252 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 31 |
| Part C:10 mg/kg LY3002813 Q4W | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Day 1 of LY3002813 | 564 microgram per milliliter (μg/mL) | Geometric Coefficient of Variation 26 |
Secondary
PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C
Cmax of LY3002813 at steady state (Day 127 \[10 mg/kg Q2W\] for part B and Day 141 \[10 mg/kg and 20 mg/kg Q4W\]) for Part C following multiple dose administration of LY3002813 was evaluated.
Time frame: Part B (Day 127): predose, end of infusion, 3, 24, 48 and 72 hours postdose; Part C (Day 141): predose, end of infusion, 3, 24, 48 and 72 hours postdose
Population: All randomized participants from part B and C who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A,B and C: Placebo | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C | 273 μg/mL | Geometric Coefficient of Variation 23 |
| Part A: 10 mg/kg LY3002813 SD | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C | 366 μg/mL | Geometric Coefficient of Variation 44 |
| Part A: 20 mg/kg LY3002813 SD | PK: Maximum Serum Concentration (Cmax) of LY3002813 at Steady State of LY3002813 in Part B and C | 598 μg/mL | Geometric Coefficient of Variation 23 |