Ascending Dose Study of the Safety and Tolerability of REGN727 (SAR236553) in Healthy Volunteers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: REGN727 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
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

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

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 ]


Enrollment:	32
Study Start Date:	March 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 Dose 1 versus placebo	Drug: REGN727 4 cohorts (dose 1, 2, 3, 4) Drug: Placebo 4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 2 Dose 2 versus placebo	Drug: REGN727 4 cohorts (dose 1, 2, 3, 4) Drug: Placebo 4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 3 Dose 3 versus placebo	Drug: REGN727 4 cohorts (dose 1, 2, 3, 4) Drug: Placebo 4 cohorts (dose 1, 2, 3, 4)
Experimental: Cohort 4 Dose 4 versus placebo	Drug: REGN727 4 cohorts (dose 1, 2, 3, 4) Drug: Placebo 4 cohorts (dose 1, 2, 3, 4)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01074372

Locations


United States, Kansas

Overland Park, Kansas, United States

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

Investigators


Study Director:	Gary Swergold, MD, PhD	Regeneron Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stein EA, Mellis S, Yancopoulos GD, Stahl N, Logan D, Smith WB, Lisbon E, Gutierrez M, Webb C, Wu R, Du Y, Kranz T, Gasparino E, Swergold GD. Effect of a monoclonal antibody to PCSK9 on LDL cholesterol. N Engl J Med. 2012 Mar 22;366(12):1108-18. doi: 10.1056/NEJMoa1105803.


Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01074372 History of Changes
Other Study ID Numbers:	R727-CL-0904
Study First Received:	February 22, 2010
Last Updated:	January 24, 2015

ClinicalTrials.gov processed this record on July 17, 2017