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Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects

NCT ID: NCT02828397

Last Updated: 2016-11-04

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

Brief Summary

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Primary Objective: Determine blood concentrations of two formulations of REGN2222

Secondary Objective: Assess safety and tolerability of REGN2222

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Reference Drug

REGN2222 Reference Formulation

Group Type EXPERIMENTAL

REGN2222

Intervention Type DRUG

Test Drug

REGN2222 Test Formulation

Group Type EXPERIMENTAL

REGN2222

Intervention Type DRUG

Interventions

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REGN2222

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy man or woman aged 18 to 60 years
2. Body weight between 50.0 kg and 95.0 kg, inclusive
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide signed informed consent

Exclusion Criteria

1. Hemoglobin not within normal limits
2. Positive drug and alcohol screen test results at screening visits 1 and 2
3. Participation in any clinical research study that evaluated 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
4. Pregnant or breastfeeding women, and women of childbearing potential
5. Sexually active men who are unwilling to practice adequate contraception during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Daytona Beach, Florida, United States

Site Status

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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R2222-HV-1520

Identifier Type: -

Identifier Source: org_study_id