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CompletedNCT01026597Updated Jan 27, 2015

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

A Phase 1 interventional study of REGN727 and Placebo in Healthy, sponsored by Regeneron Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 intravenous (I.V) infusion 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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 women.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Dose 1 versus placebo

    Drug: REGN727 · Drug: Placebo

  • Experimental
    Cohort 2

    Dose 2 versus placebo

    Drug: REGN727 · Drug: Placebo

  • Experimental
    cohort 3

    Dose 3 versus placebo

    Drug: REGN727 · Drug: Placebo

  • Experimental
    cohort 4

    Dose 4 versus placebo

    Drug: REGN727 · Drug: Placebo

  • Experimental
    cohort 5

    Dose 5 versus placebo

    Drug: REGN727 · Drug: Placebo

Interventions

  • DrugREGN727

    5 IV cohorts (dose 1, 2, 3, 4, and 5)

  • DrugPlacebo

    5 IV cohorts (dose 1, 2, 3, 4, and 5)

06

What researchers measure

Primary outcomes

  1. The primary endpoint in the study is 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

07

Study locations

1 site
  • Overland Park, Kansas, United States
08

References and documents

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. PubMed 22435370 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01026597
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Dec 4, 2009
Start date
Nov 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Jan 27, 2015

Study contacts

Gary Swergold, MD, PhD
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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