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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074372
• Other study ID #: R727-CL-0904
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2010
• Last updated: January 24, 2015
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: May 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 an injection under the skin 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 females.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN727
4 cohorts (dose 1, 2, 3, 4)
• Placebo
4 cohorts (dose 1, 2, 3, 4)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		106 days	No