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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02777151

Collaborator

Department of Health and Human Services (U.S. Fed)

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: REGN3470-3471-3479 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

May 27, 2016

Actual Primary Completion Date :

Apr 26, 2017

Actual Study Completion Date :

Apr 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 REGN3470-3471-3479 dosing level 1 or placebo	Drug: REGN3470-3471-3479 Drug: Placebo
Experimental: Cohort 2 REGN3470-3471-3479 dosing level 2 or placebo	Drug: REGN3470-3471-3479 Drug: Placebo
Experimental: Cohort 3 REGN3470-3471-3479 dosing level 3 or placebo	Drug: REGN3470-3471-3479 Drug: Placebo
Experimental: Cohort 4 REGN3470-3471-3479 dosing level 4 or placebo	Drug: REGN3470-3471-3479 Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
The presence or absence of antibodies against REGN3479 over time [From baseline up to day 169]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Evansville	Indiana	United States

Sponsors and Collaborators

Regeneron Pharmaceuticals
Department of Health and Human Services

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT02777151

Other Study ID Numbers:

R3470-3471-3479-HV-1528

First Posted:

May 19, 2016

Last Update Posted:

Feb 5, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Atoltivimab

Atoltivimab, maftivimab, and odesivimab-ebgn drug combination

Study Results

No Results Posted as of Feb 5, 2018