NCT01074372

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2010

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 27, 2015

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

February 22, 2010

Last Update Submit

January 24, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Cohort 1

EXPERIMENTAL

Dose 1 versus placebo

Drug: REGN727Drug: Placebo

Cohort 2

EXPERIMENTAL

Dose 2 versus placebo

Drug: REGN727Drug: Placebo

Cohort 3

EXPERIMENTAL

Dose 3 versus placebo

Drug: REGN727Drug: Placebo

Cohort 4

EXPERIMENTAL

Dose 4 versus placebo

Drug: REGN727Drug: Placebo

Interventions

REGN727DRUG

4 cohorts (dose 1, 2, 3, 4)

Cohort 1Cohort 2Cohort 3Cohort 4
PlaceboDRUG

4 cohorts (dose 1, 2, 3, 4)

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

Related Publications (1)

  • 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.

    PMID: 22435370DERIVED

MeSH Terms

Interventions

alirocumab

Study Officials

  • Gary Swergold, MD, PhD

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 24, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 27, 2015

Record last verified: 2011-05

Locations

US(1)