Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers

June 13, 2013 updated by: Regeneron Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study of the Safety and Tolerability of Intravenously Administered REGN668 in Healthy Volunteers

This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female 18 to 65 years of age.
  2. Weight > 50 kg and < 120 kg.
  3. For women of childbearing potential, a negative serum pregnancy test at the screening visit (visit 1) and a negative urine pregnancy test on day -1.
  4. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
  5. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full duration of the study.
  6. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
  7. Able to read, understand and willing to sign the informed consent form.

Exclusion Criteria:

  1. Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
  2. Pregnant or breast-feeding women.
  3. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
  4. Hospitalization for any reason within 60 days of screening (visit 1).
  5. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C, and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV).
  6. Previous exposure to any therapeutic or investigational biological agent. results.
  7. History of alcohol or substance abuse within previous 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 2
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 3
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)
Experimental: Dose 4
(3:1, active:placebo)
Biological: REGN668
4 IV Cohorts (Dose 1, 2, 3, & 4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN668 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 85/visit 11.
Time Frame: 85 days
85 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Serum concentrations of REGN668 over time.
Time Frame: 85 days
85 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Allen Radin, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • R668-AS-0907

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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