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

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01209793

Enrollment

Registered

2010-09-27

Start date

2010-11-30

Completion date

2011-09-30

Last updated

2012-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

BIOLOGICALREGN846

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events	Baseline through end of study

Secondary

Measure	Time frame
PK profile	Baseline through end of study
Immunogenicity	Visits 2, 8, 10 and 12

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026