Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

NCT ID: NCT01540539

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-01-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

Dosing cohort 1

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 2

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 3

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 4

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 5

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 6

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 7

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Dosing cohort 8

Group Type: EXPERIMENTAL

REGN1154 or placebo

Intervention Type: DRUG

Participants will receive active drug or placebo

Interventions

REGN1154 or placebo

Participants will receive active drug or placebo

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Melbourne, , Australia

Countries

Australia

Other Identifiers

R1154-HV-1116

Identifier Type: -

Identifier Source: org_study_id