Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: REGN1154 or placebo

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dosing cohort 1	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 2	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 3	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 4	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 5	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 6	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 7	Drug: REGN1154 or placebo; Participants will receive active drug or placebo
Experimental: Dosing cohort 8	Drug: REGN1154 or placebo; Participants will receive active drug or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number and severity of TEAEs	TEAEs (Treatment-emergent adverse events)	Day 1 through Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration	Serum concentrations of REGN1154 over time	Day 1 through Day 113
Presence or absence of antibodies	Presence or absence of antibodies against REGN1154 over time.	Day 1 through Day 113

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 27, 2012
• First Posted (Estimate): February 28, 2012

Study Record Updates

• Last Update Posted (Estimate): January 24, 2014
• Last Update Submitted That Met QC Criteria: January 23, 2014
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: R1154-HV-1116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No