CClinicalTrials.gg
CompletedNCT01209793Updated Jun 1, 2012

Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers

A Phase 1 interventional study of REGN846 in Healthy, sponsored by Regeneron Pharmaceuticals. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-01.

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 is being conducted to assess the safety and tolerability of a single ascending intravenous (IV) dose of REGN846 in healthy volunteers.

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

  • Healthy men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
  • Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, inclusive
  • Normal vital signs after resting in a sitting position for 5 minutes:
  • Normal standard 12-lead ECG
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • Able to understand and complete study-related questionnaires

Exclusion criteria

Exclusion Criteria:

  • Current or prior history of smoking
  • Any illness or condition that would adversely affect the subject's participation in this study
  • Hospitalization within 60 days of the screening visit
  • Any clinically significant abnormalities observed during the screening visit
  • History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
  • History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit
  • History of positive drug screen result for drug or alcohol abuse within a year prior to the screening visit
  • Known sensitivity to any of the components of the Investigational Product formulation
  • Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit
  • Any condition that would place the subject at risk, interfere with participation in the study
  • History of a parasitic infection or recent (within the previous 6 months) travel to a parasitic endemic area
  • Live/attenuated vaccinations within 12 weeks of screening or during the study
  • Any subjects with planned elective surgery
  • Sexually active men who are unwilling to utilize adequate contraception
05

Study design

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

Study arms

  • Experimental
    Dose 1

    (3:1, active: placebo)

    Biological: REGN846

  • Experimental
    Dose 2

    (3:1, active: placebo)

    Biological: REGN846

  • Experimental
    Dose 3

    (3:1, active: placebo)

    Biological: REGN846

  • Experimental
    Dose 4

    (3:1, active: placebo)

    Biological: REGN846

  • Experimental
    Dose 5

    (3:1, active: placebo)

    Biological: REGN846

Interventions

  • BiologicalREGN846

    5 IV cohorts (Dose 1, 2, 3, 4, 5)

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events

    Time frame: Baseline through end of study

Secondary outcomes

  1. PK profile

    Time frame: Baseline through end of study

  2. Immunogenicity

    Time frame: Visits 2, 8, 10 and 12

07

Study locations

1 site
  • Nucleus Network
    Melbourne, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01209793
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Sep 27, 2010
Start date
Nov 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jun 1, 2012

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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