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| ID | Type | Description | Link |
|---|---|---|---|
| J2F-MC-OHAA | Other Identifier | Eli Lilly and Company |
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Protocol stopping criteria (safety) were met.
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The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 milligram (mg) LY3478006 - Intravenous (IV) | Experimental | Participants received single dose of 10 mg LY3478006 administered IV. Due to early termination of the study Cohort 2 to 6 (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg LY3478006 IV) were not explored for safety reasons following dosing of the first 4 participants in Cohort 1. |
|
| Placebo - IV | Placebo Comparator | Participants received single dose of placebo administered IV. Placebo IV Cohorts 2 through 6 were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1. |
|
| 100 mg LY3478006 - Subcutaneous (SC) (Cohort 7) | Experimental | 100 mg LY3478006 cohort 7 SC dose was not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1. |
|
| Placebo - SC (Cohort 7) | Placebo Comparator | Placebo cohort 7 SC dose were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3478006 - IV | Drug | Administered IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | Baseline through study completion (up to 109 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006 | Cmax of LY3478006 was evaluated. | Predose; Day 1 with end of infusion, 3, 6, 12 hours |
| PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006 |
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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 |
|---|---|---|---|---|---|---|
| Covance | Dallas | Texas | 75247 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Milligram (mg) LY3478006 - Intravenous (IV) | Participants received single dose of 10 mg LY3478006 administered IV. |
| FG001 | Placebo - IV | Participants received single dose of placebo administered IV. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg LY3478006 - IV | Participants received single dose of 10 mg LY3478006 administered IV. |
| BG001 | Placebo - IV | Participants received single dose of placebo 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) Considered by the Investigator to be Related to Study Drug Administration | Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through study completion (up to 109 days) |
|
Baseline through study completion (up to 109 days)
All randomized participants who received at least one dose of study drug.
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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 | 10 mg LY3478006 IV | Participants received single dose of placebo administered IV. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
Cohort 2 through 7 were not explored as study was terminated early for safety reasons after Cohort 1.
| 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 | Dec 26, 2019 | Mar 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2020 | Mar 22, 2021 | SAP_001.pdf |
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| LY3478006 - SC |
| Drug |
Administered SC |
|
| Placebo - IV | Drug | Administered IV |
|
| Placebo - SC | Drug | Administered SC |
|
AUC0-∞ of LY3478006 was evaluated. The unit of measure is hour*microgram per milliliter (hr*mcg/mL).
| Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received single dose of placebo administered IV. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006 | Cmax of LY3478006 was evaluated. | All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Predose; Day 1 with end of infusion, 3, 6, 12 hours |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006 | AUC0-∞ of LY3478006 was evaluated. The unit of measure is hour*microgram per milliliter (hr*mcg/mL). | All randomized participants who received at least one dose of study drug and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*mcg/mL | Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85 |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| 3 |
| 3 |
| EG001 | Placebo IV | Participants received single dose of 10 mg LY3478006 administered IV. | 0 | 1 | 0 | 1 | 0 | 1 |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment | One participant SAE was resolved after study completion with resolution occurring on day 138. |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
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