Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/7/2018 |
Start Date: | May 27, 2016 |
End Date: | April 26, 2017 |
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered REGN3470-3471-3479 in Healthy Adult Subjects
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.
evaluating the safety, tolerability, pharmacokinetics (PK) and immunogenicity of
REGN3470-3471-3479 in healthy adult volunteers.
Inclusion Criteria:
1. Healthy man or woman between the ages of 18 and 60
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent
5. Able to understand and complete study-related questionnaires
Exclusion Criteria:
1. 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
2. Hospitalization for any reason within 60 days prior to the screening visit
3. History of or positive human immunodeficiency virus (HIV) screen result at the
screening visit
4. 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
5. History of drug or alcohol abuse within 1 year prior to screening
6. 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
7. Any history of receiving treatment, vaccine or mAbs against the Ebola virus
8. Pregnant or breast-feeding women
9. 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.
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