NCT02777151
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- REGN3470-3471-3479
- Conditions
- Healthy Volunteers
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 24
- Primary Endpoint
- Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 1
REGN3470-3471-3479 dosing level 1 or placebo
Intervention: REGN3470-3471-3479
Cohort 1
REGN3470-3471-3479 dosing level 1 or placebo
Intervention: Placebo
Cohort 2
REGN3470-3471-3479 dosing level 2 or placebo
Intervention: REGN3470-3471-3479
Cohort 2
REGN3470-3471-3479 dosing level 2 or placebo
Intervention: Placebo
Cohort 3
REGN3470-3471-3479 dosing level 3 or placebo
Intervention: REGN3470-3471-3479
Cohort 3
REGN3470-3471-3479 dosing level 3 or placebo
Intervention: Placebo
Cohort 4
REGN3470-3471-3479 dosing level 4 or placebo
Intervention: REGN3470-3471-3479
Cohort 4
REGN3470-3471-3479 dosing level 4 or placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
Time Frame: From baseline up to day 169
Secondary Outcomes
- Concentration of REGN3470 in serum over time(From baseline up to day 169)
- 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)
- 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)
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