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| ID | Type | Description | Link |
|---|---|---|---|
| J2X-MC-PYAG | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3819253 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 |
|---|---|---|---|
| LY3819253 | Experimental | Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253. |
|
| Placebo | Placebo Comparator | Participants received a single SC dose of Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3819253 | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 | PK: AUC[0-∞] of LY3819253 | Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo SC | Participants received a single subcutaneous (SC) dose of Placebo. |
| FG001 | 150 Milligram (mg) LY3819253 SC | Participants received a single SC dose of 150 mg LY3819253. |
| FG002 | 350 mg LY3819253 SC | Participants received a single SC dose of 350 mg LY3819253. |
| FG003 | 700 mg LY3819253 SC | Participants received a single SC dose of 700 mg LY3819253. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SC | Participants received a single SC dose of Placebo. |
| BG001 | 150 mg LY3819253 SC | Participants received a single SC dose of 150 mg LY3819253. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Zero to Infinity (AUC[0-∞]) of LY3819253 | PK: AUC[0-∞] of LY3819253 | All randomized participants who received at least one dose of LY3819253 and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day per milliliter(μg*day/mL) | Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose |
|
Baseline to Follow-up (up to 85 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 | Placebo SC | Participants received a single SC dose of Placebo. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faeces discoloured | Gastrointestinal 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 | Oct 14, 2020 | Jul 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2020 | Jul 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000711749 | bamlanivimab |
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| Placebo | Drug | Administered SC. |
|
| BG002 | 350 mg LY3819253 SC | Participants received a single SC dose of 350 mg LY3819253. |
| BG003 | 700 mg LY3819253 SC | Participants received a single SC dose of 700 mg LY3819253. |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| OG002 | 700 mg LY3819253 SC | Participants received a single SC dose of 700 mg LY3819253. |
|
|
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | 150 mg LY3819253 SC | Participants received a single SC dose of 150 mg LY3819253. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | 350 mg LY3819253 SC | Participants received a single SC dose of 350 mg LY3819253. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG003 | 700 mg LY3819253 SC | Participants received a single SC dose of 700 mg LY3819253. | 0 | 7 | 0 | 7 | 0 | 7 |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.