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| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
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This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of REGN3470-3471-3479 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | REGN3470-3471-3479 dosing level 1 or placebo |
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| Cohort 2 | Experimental | REGN3470-3471-3479 dosing level 2 or placebo |
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| Cohort 3 | Experimental | REGN3470-3471-3479 dosing level 3 or placebo |
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| Cohort 4 | Experimental | REGN3470-3471-3479 dosing level 4 or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN3470-3471-3479 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination | From baseline up to day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of REGN3479 in serum over time | From baseline up to day 169 | |
| Concentration of REGN3471 in serum over time | From baseline up to day 169 | |
| Concentration of REGN3470 in serum over time |
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Inclusion Criteria:
Exclusion Criteria:
Use of any medications started within 30 days prior to the screening visit including, prescription medications, nutritional supplements, and over-the-counter medications except for vitamin supplements, and recommended doses of acetaminophen, aspirin or ibuprofen
Hospitalization for any reason within 60 days prior to the screening visit
History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
History of or positive blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody at the screening visit
History of drug or alcohol abuse within 1 year prior to screening
Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
Any history of receiving treatment, vaccine or mAbs against the Ebola virus
Pregnant or breast-feeding women
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evansville | Indiana | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29929783 | Derived | Sivapalasingam S, Kamal M, Slim R, Hosain R, Shao W, Stoltz R, Yen J, Pologe LG, Cao Y, Partridge M, Sumner G, Lipsich L. Safety, pharmacokinetics, and immunogenicity of a co-formulated cocktail of three human monoclonal antibodies targeting Ebola virus glycoprotein in healthy adults: a randomised, first-in-human phase 1 study. Lancet Infect Dis. 2018 Aug;18(8):884-893. doi: 10.1016/S1473-3099(18)30397-9. Epub 2018 Jun 18. |
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| ID | Term |
|---|---|
| C000711952 | atoltivimab, maftivimab, and odesivimab-ebgn drug combination |
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| Drug |
|
| From baseline up to day 169 |
| The presence or absence of antibodies against REGN3470 over time | From baseline up to day 169 |
| The presence or absence of antibodies against REGN3471 over time | From baseline up to day 169 |
| The presence or absence of antibodies against REGN3479 over time | From baseline up to day 169 |