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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: REGN727; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Gary Swergold, MD, PhD, Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 24, 2015
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: R727-CL-0904