Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540539
• Other study ID #: R1154-HV-1116
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2012
• Last updated: January 23, 2014
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardAustralia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN1154 or placebo
Participants will receive active drug or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number and severity of TEAEs	TEAEs (Treatment-emergent adverse events)	Day 1 through Day 113	Yes
Secondary	Serum concentration	Serum concentrations of REGN1154 over time	Day 1 through Day 113	No
Secondary	Presence or absence of antibodies	Presence or absence of antibodies against REGN1154 over time.	Day 1 through Day 113	No