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| ID | Type | Description | Link |
|---|---|---|---|
| J2Z-MC-PGAA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3832479 | Experimental | Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479. |
|
| Placebo | Placebo Comparator | Participants received single IV dose of Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3832479 | 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 | The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline through Follow-up (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC[0-∞]) of LY3832479. | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 |
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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 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 | Pooled Placebo | Participants received single Intravenous (IV) dose of Placebo. |
| FG001 | 700 mg LY3832479 IV | Participants received single IV dose of 700 mg LY3832479. |
| FG002 | 2800 mg LY3832479 IV | Participants received single IV dose of 2800 mg LY3832479. |
| FG003 | 7000 mg LY3832479 IV | Participants received single IV dose of 7000 mg LY3832479. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pooled Placebo | Participants received single Intravenous (IV) dose of Placebo. |
| BG001 | 700 mg LY3832479 IV | Participants received single IV dose of 700 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who received at least one dose of study drug. | Posted | Number | Participants | Baseline through Follow-up (Week 12) |
|
Baseline, upto 3 Months
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 | Pooled Placebo IV | Participants received single Intravenous (IV) dose of Placebo. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | 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 | Jul 15, 2020 | Oct 25, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2020 | Oct 25, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000711968 | etesevimab |
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| Placebo | Drug | Administered IV. |
|
| PK: Maximum Serum Concentration (Cmax) of LY3832479 |
PK: Maximum Serum Concentration (Cmax) of LY3832479. |
| Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 |
| BG002 | 2800 mg LY3832479 IV | Participants received single IV dose of 2800 mg LY3832479. |
| BG003 | 7000 mg LY3832479 IV | Participants received single IV dose of 7000 mg LY3832479. |
| BG004 | 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 |
|
| OG001 | 700 mg LY3832479 IV | Participants received single IV dose of 700 mg LY3832479. |
| OG002 | 2800 mg LY3832479 IV | Participants received single IV dose of 2800 mg LY3832479. |
| OG003 | 7000 mg LY3832479 IV | Participants received single IV dose of 7000 mg LY3832479. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC[0-∞]) of LY3832479. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*day per milliliter(ug*day/mL) | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 |
|
|
|
| Secondary | PK: Maximum Serum Concentration (Cmax) of LY3832479 | PK: Maximum Serum Concentration (Cmax) of LY3832479. | All randomized participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 700 mg LY3832479 IV | Participants received single IV dose of 700 mg LY3832479. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | 2800 mg LY3832479 IV | Participants received single IV dose of 2800 mg LY3832479. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG003 | 7000 mg LY3832479 IV | Participants received single IV dose of 7000 mg LY3832479. | 0 | 6 | 0 | 6 | 0 | 6 |
| Covid-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Sars-cov-2 test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
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