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Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

NCT ID: NCT01893528

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-09-30

Brief Summary

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This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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REGN2009 dose level 1

Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Group Type EXPERIMENTAL

REGN2009

Intervention Type DRUG

placebo

Intervention Type OTHER

REGN2009 dose level 2

Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Group Type EXPERIMENTAL

REGN2009

Intervention Type DRUG

placebo

Intervention Type OTHER

REGN2009 dose level 3

Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Group Type EXPERIMENTAL

REGN2009

Intervention Type DRUG

placebo

Intervention Type OTHER

Interventions

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REGN2009

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Healthy men and women ages 18 to 65 years inclusive
2. Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive

Exclusion Criteria

1. Pregnant or breast-feeding women
2. Any clinically significant abnormalities observed during screening (day -21 to day -2)
3. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
4. History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
5. Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
6. Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
7. History of a hypersensitivity reaction to doxycycline or similar compound
8. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
9. Previous adverse experience to any biological investigational or therapeutic agent
10. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Baltimore, Maryland, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R2009-HV-1304

Identifier Type: -

Identifier Source: org_study_id