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| ID | Type | Description | Link |
|---|---|---|---|
| J2Z-MC-PGAB | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Shanghai Junshi Bioscience Co., Ltd. | OTHER |
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The purpose of this study is to test the safety and tolerability of LY3832479 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3832479 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3832479 | Experimental | Participants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479. |
|
| Placebo | Placebo Comparator | Participants received single subcutaneous dose of Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3832479 | Drug | Administered subcutaneously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC[0-tlast]) of LY3832479. | Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose |
| PK: Maximum Serum Concentration (Cmax) of LY3832479 | PK: Maximum Serum Concentration (Cmax) of LY3832479. | Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose |
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Inclusion Criteria:
Exclusion Criteria:
Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of
Have significant allergies to humanized monoclonal antibodies (mAbs)
Have any of the following that are clinically significant:
Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Have had breast cancer within the past 10 years
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus [HCV] ribonucleic acid [RNA])
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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 Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received single subcutaneous dose of Placebo. |
| FG001 | 350 mg LY3832479 | Participants received single subcutaneous dose of 350 mg LY3832479. |
| FG002 | 1000 mg LY3832479 | Participants received single subcutaneous dose of 1000 mg LY3832479. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received single subcutaneous dose of Placebo. |
| BG001 | 350 mg LY3832479 | Participants received single subcutaneous dose of 350 mg LY3832479. |
| 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 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC[0-tlast]) of LY3832479. | All randomized participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter (μg*day/mL) | Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose |
|
Baseline, upto 3 Months
All randomized participants.
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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 SC | Participants received single subcutaneous dose of Placebo. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
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| 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 | Sep 30, 2020 | Oct 25, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2020 | Oct 25, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000711968 | etesevimab |
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| Placebo | Drug | Administered subcutaneously |
|
| BG002 | 1000 mg LY3832479 | Participants received single subcutaneous dose of 1000 mg LY3832479. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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|
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| Primary | PK: Maximum Serum Concentration (Cmax) of LY3832479 | PK: Maximum Serum Concentration (Cmax) of LY3832479. | All randomized participants who received study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose |
|
|
|
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 350 mg LY3832479 SC | Participants received single subcutaneous dose of 350 mg LY3832479. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | 1000 mg LY3832479 SC | Participants received single subcutaneous dose of 1000 mg LY3832479. | 0 | 7 | 0 | 7 | 1 | 7 |
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