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| ID | Type | Description | Link |
|---|---|---|---|
| J5Z-MC-OTAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to explore the safety and any side effects of LY4066708 in healthy participants. The study will also measure how much LY4066708 gets into the bloodstream and the central nervous system and how long it takes the body to remove it. The study will last up to 24 weeks for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort 1: Single-Ascending Dose (SAD)- LY4066708 | Experimental | LY4066708 administered by intravenous (IV) injection |
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| Part A Cohort 2: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
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| Part A Cohort 3A: SAD- LY4066708 | Experimental | LY4066708 administered by subcutaneous (SC) injection |
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| Part A Cohort 3B: SAD- LY4066708 | Experimental | LY4066708 administered by SC injection |
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| Part A Cohort 4: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
|
| Part A Cohort 5: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4066708 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants with One or More Serious Adverse Events (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, will be reported in the Adverse Events module | Baseline up to Week 12 |
| Part B: Number of Participants with One or More Serious Adverse Events (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, will be reported in the Adverse Events module | Screening to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Pharmacokinetics (PK)- Area Under the Plasma Concentration Versus Time Curve (AUC0-168) | To evaluate PK after a single dose of LY4066708 | Predose up to day 15 |
| Part B: Pharmacokinetics (PK)- AUC0-168 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Recruiting | Holbeck, Leeds | LS11 9EH | United Kingdom |
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| Part A Cohort 5A: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
|
| Part A Cohort 6A: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
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| Part A Cohort 6: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
|
| Part B Cohort 1: Multiple-Ascending Dose (MAD)- LY4066708 | Experimental | LY4066708 administered by IV injection |
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| Part B Cohort 2: MAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
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| Part B Cohort 3: MAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
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| Part B Cohort 4: MAD- LY4066708 | Experimental | LY4066708 administered by IV injection |
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| Placebo | Placebo Comparator | Placebo administered by IV injection |
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| Placebo- Part A Cohort 3A and Part A Cohort 3B. | Placebo Comparator | Placebo administered by SC injection |
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| Placebo | Drug | Administered IV |
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| LY4066708 | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
To evaluate PK after multiple doses of LY4066708
| Day 1 up to day 7 |
| Part A: Pharmacokinetics (PK)- Maximum Observed Drug Concentration (Cmax) | To evaluate PK after a single dose of LY4066708 | Predose up to day 15 |
| Part B: Pharmacokinetics (PK)- Cmax | To evaluate PK after a single dose of LY4066708 | After dose 3, up to day 64 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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