An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:2/8/2015
Start Date:August 2013
End Date:January 2015
Contact:Adminstrator Clinical Trials
Email:clinicaltrials@regeneron.com

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Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy
volunteers.


Inclusion Criteria:

1. Healthy men and women 18 to 45 years of age (inclusive)

2. Body mass index 18.0 to 30.0 kg/m^2 (inclusive)

3. Normal standard 12-lead ECG

4. Willing and able to comply with clinic visits and study-related procedures

5. Provide signed informed consent

6. For sexually active men and women of childbearing potential, willingness to utilize
adequate contraception and not become pregnant (or have their partner[s] become
pregnant) during and for up to 3 months after participation in the study.

Exclusion Criteria:

1. Any clinically significant abnormalities or other characteristics that would preclude
the subject from safely enrolling or successfully completing the study

2. History of drug or alcohol abuse within a year prior to the screening visit

3. Current regular smoking, or a history of smoking greater than ½ pack

4. Receipt of an investigational drug within 30 days of screening, or within 5
half-lives of the investigational drug or therapy being studied (whichever is
longer)

5. 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 may adversely affect the subject's participation in this
study

6. Known history of human immunodeficiency virus (HIV) antibody; and/or positive
hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at
the screening visit

7. Hospitalization for any reason within 60 days of screening

8. History or presence of malignancy (including carcinoma in situ) prior to the
screening visit

9. Any subject who is the investigator or any sub-investigator, research assistant,
pharmacist, study coordinator, or other staff directly involved in the conduct of the
protocol, or family member of staff involved in the conduct of the protocol

10. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all
considerations relevant to a subject's potential participation in this clinical trial).
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