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

NCT02777151 | Completed Phase 1

• 1 other identifier: R3470-3471-3479-HV-1528
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination

  From baseline up to day 169

Secondary Outcomes (6)

• 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

• Concentration of REGN3470 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

REGN3470-3471-3479 dosing level 1 or placebo

Drug: REGN3470-3471-3479; Drug: Placebo

Cohort 2

EXPERIMENTAL

REGN3470-3471-3479 dosing level 2 or placebo

Drug: REGN3470-3471-3479; Drug: Placebo

Cohort 3

EXPERIMENTAL

REGN3470-3471-3479 dosing level 3 or placebo

Drug: REGN3470-3471-3479; Drug: Placebo

Cohort 4

EXPERIMENTAL

REGN3470-3471-3479 dosing level 4 or placebo

Drug: REGN3470-3471-3479; Drug: Placebo

Interventions

REGN3470-3471-3479 DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Unknown Facility

Evansville, Indiana, United States

Location

Related Publications (1)

• 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.

  PMID: 29929783 DERIVED

MeSH Terms

Interventions

atoltivimab, maftivimab, and odesivimab-ebgn drug combination

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: May 27, 2016
• Primary Completion: April 26, 2017
• Study Completion: April 26, 2017
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)