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| ID | Type | Description | Link |
|---|---|---|---|
| I8G-MC-LMDA | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and tolerability of the study drug, LY3303560. Side effects and laboratory results will be monitored. This study will involve single doses of LY3303560 administered intravenously (IV), meaning into a vein or subcutaneously (SC), meaning under the skin.
Screening is required within 28 days before the start of the study for healthy participants and within 70 days before the start of the study for AD participants. The study requires about 16 weeks of each participant's time including a 4 day clinical research unit (CRU) admission and 10 follow-up appointments.
This is the first time that this study drug is being given to participants. This study is for research purposes only, and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3303560 | Experimental | Single IV infusion 7 milligram (mg), 21 mg, 70 mg, 210 mg, 700 mg, 1400 mg, 2800 mg, and 5600 mg of LY3303560 on Day 1 in healthy participants. |
|
| Saline Solution | Placebo Comparator | Single IV infusion of saline solution to match LY3303560 on Day 1 in healthy participants. |
|
| LY3303560 Subcutaneous (SC) | Experimental | Single SC injection of 210 mg LY3303560 on Day 1 in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3303560 - IV | Drug | Administered IV |
| |
| Saline Solution - IV |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration | Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline up to 146 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560 | Serum PK: AUC. Statistical analysis was not pre-specified. | Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Parexel Early Phase Unit at Glendale | Glendale | California | 91206 | United States | ||
| PAREXEL-Phase 1 Baltimore Harbor Hospital Center |
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| Label | URL |
|---|---|
| Click here for more information about this study: A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered as an intravenous (IV) single dose on Day 1. |
| FG001 | 7 mg LY3303560 | 7 milligram (mg) LY3303560 single dose administered intravenously (IV) on Day 1. |
| FG002 | 21 mg LY3303560 | 21 mg LY3303560 single dose administered IV on Day 1. |
| FG003 | 70 mg LY3303560 | 70 mg LY3303560 single dose administered IV on Day 1. |
| FG004 | 210 mg LY3303560 | 210 mg LY3303560 single dose administered IV on Day 1. |
| FG005 | 210 mg LY3303560 Subcutaneous | 210 mg LY3303560 single dose administered subcutaneously (SC) on Day 1. |
| FG006 | 700 mg LY3303560 | 700 mg LY3303560 single dose administered IV on Day 1. |
| FG007 | 1400 mg LY3303560 | 1400 mg LY3303560 single dose administered IV on Day 1. |
| FG008 | 2800 mg LY3303560 | 2800 mg LY3303560 single dose administered IV on Day 1. |
| FG009 | 5600 mg LY3303560 | 5600 mg LY3303560 single dose administered IV on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo single dose administered IV. |
| BG001 | 7 mg LY3303560 | 7 mg LY3303560 single dose administered IV. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Serious Adverse Event(s) (SAEs) to be Related to Study Drug Administration | Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of other nonserious adverse events (AEs), and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All enrolled participants. | Posted | Count of Participants | Participants | No | Baseline up to 146 days |
|
Baseline up to 146 days
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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 | Placebo single dose administered IV. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
Planned doses of 2800 mg and 5600 mg in AD participants were not implemented.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | 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 | Jul 31, 2017 | Feb 11, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2016 | Oct 6, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Drug |
Administered IV |
|
| LY3303560 - SC | Drug | Administered SC |
|
| PK: Maximum Drug Concentration (Cmax) of LY3303560 | Serum PK: Cmax. Statistical analysis was not pre-specified. | Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose |
| Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD) | Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose |
| Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD) | Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose |
| Mean Change From Baseline in QT/QT Corrected (QTc) Interval | Mean change from baseline in QT/QTc intervals using Fridericia's formula [Fridericia's corrected QT(QTcF)] from ECG monitoring. | Baseline, 7 days postdose |
| Baltimore |
| Maryland |
| 21225 |
| United States |
| BG002 |
| 21 mg LY3303560 |
21 mg LY3303560 single dose administered IV. |
| BG003 | 70 mg LY3303560 | 70 mg LY3303560 single dose administered IV. |
| BG004 | 210 mg LY3303560 | 210 LY3303560 single dose administered IV. |
| BG005 | 210 mg LY3303560 SC | 210 mg LY3303560 single dose administered SC. |
| BG006 | 700 mg LY3303560 | 700 mg LY3303560 single dose administered IV. |
| BG007 | 1400 mg LY3303560 | 1400 mg LY3303560 single dose administered IV. |
| BG008 | 2800 mg LY3303560 | 2800 mg LY3303560 single dose administered IV. |
| BG009 | 5600 mg LY3303560 | 5600 mg LY3303560 single dose administered IV. |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | 21 mg LY3303560 | 21 mg LY3303560 single dose administered IV. |
| OG003 | 70 mg LY3303560 | 70 mg LY3303560 single dose administered IV. |
| OG004 | 210 mg LY3303560 | 210 mg LY3303560 single dose administered IV. |
| OG005 | 210 mg LY3303560 SC | 210 mg LY3303560 single dose administered SC. |
| OG006 | 700 mg LY3303560 | 700 mg LY3303560 single dose administered IV. |
| OG007 | 1400 mg LY3303560 | 1400 mg LY3303560 single dose administered IV. |
| OG008 | 2800 mg LY3303560 | 2800 mg LY3303560 single dose administered IV. |
| OG009 | 5600 mg LY3303560 | 5600 mg LY3303560 single dose administered IV. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3303560 | Serum PK: AUC. Statistical analysis was not pre-specified. | All participants who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per millliliter(µg*hr/mL) | Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose |
|
|
|
| Secondary | PK: Maximum Drug Concentration (Cmax) of LY3303560 | Serum PK: Cmax. Statistical analysis was not pre-specified. | All participants who had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/millliliter (µg/mL) | Day 1: Predose, 0.5, 2, 4, 12, 24, 48, 72, 96, 120, 144, 360, 528, 696, 1032, 1368, 1704, 2040 hours post-dose; additionally, for 2800 mg and 5600 mg: 2712 and 3384 hours postdose |
|
|
|
| Secondary | Pharmacokinetics (Cerebrospinal Fluid): Area Under the Concentration Versus Time Curve (AUC) of LY3303560 in Participants With Alzheimer's' Disease (AD) | Zero participants were analyzed as no AD and Mild Cognitive Impairment (MCI) participants were enrolled. | Posted | Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose |
|
|
| Secondary | Pharmacokinetics (Cerebrospinal Fluid): Maximum Drug Concentration (Cmax) of LY3303560 in Participants With Alzheimer's' Disease (AD) | Zero participants were analyzed as no AD and MCI participants were enrolled. | Posted | Day 1: Predose, 0, 2, 4, 12, 24, and 36 hours post-dose |
|
|
| Secondary | Mean Change From Baseline in QT/QT Corrected (QTc) Interval | Mean change from baseline in QT/QTc intervals using Fridericia's formula [Fridericia's corrected QT(QTcF)] from ECG monitoring. | All enrolled participants. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline, 7 days postdose |
|
|
|
| 17 |
| 0 |
| 17 |
| 6 |
| 17 |
| EG001 | 7 mg LY3303560 | 7mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | 21 mg LY3303560 | 21 mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | 70 mg LY3303560 | 70 mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | 210 mg LY3303560 | 210 mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | 210 mg LY3303560 SC | 210 mg LY3303560 single dose administered SC. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | 700 mg LY3303560 | 700 mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG007 | 1400 mg LY3303560 | 1400 mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG008 | 2600 mg LY3303560 | 2600 mg LY3303560 single dose administered IV. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG009 | 5600 mg LY3303560 | 5600 mg LY3303560 single dose administered IV. | 0 | 6 | 0 | 6 | 4 | 6 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Defaecation urgency | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Vessel puncture site haemorrhage | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Bradyphrenia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |