Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01209793




Registration number
NCT01209793
Ethics application status
Date submitted
24/09/2010
Date registered
27/09/2010
Date last updated
1/06/2012

Titles & IDs
Public title
Safety and Tolerability Study of REGN846 (SAR302352) in Healthy Volunteers
Scientific title
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety and Tolerability of Intravenously Administered REGN846 (SAR302352) in Healthy Volunteers
Secondary ID [1] 0 0
R846-HV-1007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - REGN846

Experimental: Dose 1 - (3:1, active: placebo)

Experimental: Dose 2 - (3:1, active: placebo)

Experimental: Dose 3 - (3:1, active: placebo)

Experimental: Dose 4 - (3:1, active: placebo)

Experimental: Dose 5 - (3:1, active: placebo)


Treatment: Other: REGN846
5 IV cohorts (Dose 1, 2, 3, 4, 5)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
Baseline through end of study
Secondary outcome [1] 0 0
PK profile
Timepoint [1] 0 0
Baseline through end of study
Secondary outcome [2] 0 0
Immunogenicity
Timepoint [2] 0 0
Visits 2, 8, 10 and 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01209793
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01209793