Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers

Inclusion criteria

• Healthy man or woman between the ages of 18 and 60
• Body mass index (BMI) between 18 and 30 kg/m2, inclusive
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Able to understand and complete study-related questionnaires

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).

• Contraception is not required for men with documented vasectomy.
• Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. A baseline follicle-stimulating hormone (FSH) test will be performed for confirmation of menopausal status. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.