NCT01015027

Brief Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2009

Typical duration for phase_1 healthy

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

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

9 months

First QC Date

November 10, 2009

Last Update Submit

June 13, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN668 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 85/visit 11.

    85 days

Secondary Outcomes (1)

  • Pharmacokinetics: Serum concentrations of REGN668 over time.

    85 days

Study Arms (4)

Dose 1

EXPERIMENTAL

(3:1, active:placebo)

Biological: REGN668

Dose 2

EXPERIMENTAL

(3:1, active:placebo)

Biological: REGN668

Dose 3

EXPERIMENTAL

(3:1, active:placebo)

Biological: REGN668

Dose 4

EXPERIMENTAL

(3:1, active:placebo)

Biological: REGN668

Interventions

REGN668BIOLOGICAL

4 IV Cohorts (Dose 1, 2, 3, \& 4)

Dose 1Dose 2Dose 3Dose 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 \< 120 kg.
  • For women of childbearing potential, a negative serum pregnancy test at the screening visit (visit 1) and a negative urine pregnancy test on day -1.
  • Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.
  • 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:

  • Onset 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 (visit 1).
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C, and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV).
  • Previous exposure to any therapeutic or investigational biological agent. results.
  • History of alcohol or substance abuse within previous 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Baltimore, Maryland, United States

Location

Related Publications (1)

  • Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.

    PMID: 32348036DERIVED

MeSH Terms

Interventions

dupilumab

Study Officials

  • Allen Radin

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 17, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

US(1)