Clinical trial NCT02777151: Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2016-05-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
timeFrame: From baseline up to day 169
Secondary outcomes:
measure: Concentration of REGN3479 in serum over time
timeFrame: From baseline up to day 169
measure: Concentration of REGN3471 in serum over time
timeFrame: From baseline up to day 169
measure: Concentration of REGN3470 in serum over time
timeFrame: From baseline up to day 169
measure: The presence or absence of antibodies against REGN3470 over time
timeFrame: From baseline up to day 169
measure: The presence or absence of antibodies against REGN3471 over time
timeFrame: From baseline up to day 169
measure: The presence or absence of antibodies against REGN3479 over time
timeFrame: From baseline up to day 169
Other outcomes:
Locations:
city: Evansville
country: United States
state: Indiana
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: 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.