Ascending Dose Study of the Safety and Tolerability of REGN727(SAR236553) in Healthy Volunteers

This study will test the safety and tolerability (how the body reacts to the drug) of REGN727 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by intravenous (I.V) infusion at one clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female 18 to 65 years of age.
Weight> 50 kg and <95 kg inclusive
For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day 1.
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.
Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
Able to read, understand and willing to sign the informed consent form.

Exclusion criteria

Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
Pregnant or breast-feeding women.
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.
Hospitalization for any reason within 60 days of screening.
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.
Previous exposure to any therapeutic or investigational biological agent.
History of alcohol or substance abuse within previous 5 years.

Treatment and study plan

REGN727

Drug

5 IV cohorts (dose 1, 2, 3, 4, and 5)

Placebo

Drug

5 IV cohorts (dose 1, 2, 3, 4, and 5)

Primary outcomes

The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106.

Time frame: 106 days

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

Sanofi

Registry information

Official study title

A Randomized,Double-Blind,Placebo-Controlled,Ascending,Single-Dose Study of the Safety,Tolerability and Bioeffect of Intravenously Administered REGN727 in Healthy Volunteers

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 4, 2009
Registry last updated: Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed