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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01540539




Registration number
NCT01540539
Ethics application status
Date submitted
23/02/2012
Date registered
28/02/2012
Date last updated
24/01/2014

Titles & IDs
Public title
Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers
Scientific title
Secondary ID [1] 0 0
R1154-HV-1116
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - REGN1154 or placebo

Experimental: Dosing cohort 1 -

Experimental: Dosing cohort 2 -

Experimental: Dosing cohort 3 -

Experimental: Dosing cohort 4 -

Experimental: Dosing cohort 5 -

Experimental: Dosing cohort 6 -

Experimental: Dosing cohort 7 -

Experimental: Dosing cohort 8 -


Treatment: Drugs: REGN1154 or placebo
Participants will receive active drug or placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total number and severity of TEAEs
Timepoint [1] 0 0
Day 1 through Day 113
Secondary outcome [1] 0 0
Serum concentration
Timepoint [1] 0 0
Day 1 through Day 113
Secondary outcome [2] 0 0
Presence or absence of antibodies
Timepoint [2] 0 0
Day 1 through Day 113

Eligibility
Key inclusion criteria
1. Healthy men and women between the ages of 18 and 65; women must be postmenopausal or
surgically sterile

2. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive

3. Willing, committed, and able to return for ALL clinic visits and complete all
study-related procedures

4. Able to read or to understand the consent process, and willing to sign the informed
consent form (ICF)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include, but are not limited to the following:

1. Any illness or condition that would adversely affect the subject's participation in
this study

2. Any clinically significant abnormalities observed during the screening visit

3. Use of certain medications taken before the screening visit

4. Onset of a new exercise routine or major change to a previous exercise routine within
4 weeks prior to screening visit

5. Hospitalization within 60 days of the screening visit

6. Any condition that would place the subject at risk, interfere with participation in
the study

7. History of or positive human immunodeficiency virus (HIV) screen result at the
screening visit

8. History of certain other conditions

9. Positive urine, drug or alcohol screen result at screening

10. Known sensitivity to any of the components of the investigational product formulation

11. 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

12. Live/attenuated vaccinations within 12 weeks of screening or during the study

Study design
Purpose of the study
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to study the safety and tolerability of intravenous (IV) and
subcutaneous (SC) administration of REGN1154 in normal healthy subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01540539
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/ct2/show/NCT01540539