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This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in cohorts of healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dosing regimen 1 |
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| Cohort 2 | Experimental | Dosing regimen 2 |
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| Cohort 3 | Experimental | Dosing regimen 3 |
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| Cohort 4 | Experimental | Dosing regimen 4 |
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| Cohort 5 | Experimental | Dosing regimen 5 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN2222(SAR438584) | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo. | from day 1 up to week 20 (EOS) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration | Serum concentration of REGN2222 over time up to week 20 | from day 1 over time up to week 20 |
| Presence or absence of antibodies | The presence or absence of antibodies against REGN2222 over time up to week 20 |
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Inclusion Criteria:
Exclusion Criteria:
Serum hemoglobin, creatinine, alkaline phosphatase, CPK, and/or hepatic enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT], total bilirubin [unless the investigator has evidence that increased bilirubin corresponds to a Gilbert's type syndrome with elevated indirect bilirubin]) that is >1.5 the upper limit of normal (ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant abnormalities from the normal range, as determined by the investigator at the screening visit
Use of any concomitant medications within 30 days or at least 5 half-lives, whichever is longer, of the screening visit, including prescription medications (except contraceptives), nutritional supplements, and over-the-counter medications (except acetaminophen)
Hospitalization for any reason within 60 days of the screening visit
History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
History of or positive blood test result for hepatitis B surface antigen and/or hepatitis C virus antibody at the screening visit
History of autoimmune disease
History of respiratory disease (e.g, asthma, chronic obstructive pulmonary disease)
History of drug or alcohol abuse within 1 year prior to the screening visit
Participation in any clinical research study evaluating another investigational drug or therapy within 30 days, or within at least 5 half-lives, of the investigational drug (whichever is longer) prior to the screening visit
Pregnant or breastfeeding woman
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study, and up to 3 months after the last dose of the study drug (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; 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 |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | United States | ||||
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| placebo |
| Drug |
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| from day 1 over time up to week 20 |
| Evansville |
| Indiana |
| United States |
| Dallas | Texas | United States |