Status:
COMPLETED
Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will test the safety and tolerability (how the body reacts to the drug) of REGN728 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study dru...
Eligibility Criteria
Inclusion
- Male or female 18 to 65 years of age.
- Weight\> 50 kg and \<95 kg inclusive
- For men of childbearing potential, willingness to utilize adequate contraception and not 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
- Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
- Women of childbearing potential, pregnant and breast-feeding women are excluded. Women are considered to be of childbearing potential until they have been amenorrheic for at least 12 months or have had surgical sterilization.
- 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 a year prior to the screening visit.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01197391
Start Date
August 1 2010
End Date
March 1 2012
Last Update
November 12 2012
Active Locations (2)
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1
Miramar, Florida, United States
2
Overland Park, Kansas, United States