Intravenous/Subcutaneous FIH Study of REGN1154 in Healthy Volunteers

NCT01540539 | Completed Phase 1 DMC

• 1 other identifier: R1154-HV-1116
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total number and severity of TEAEs

  TEAEs (Treatment-emergent adverse events)

  Day 1 through Day 113

Secondary Outcomes (2)

• Serum concentration

  Day 1 through Day 113

• Presence or absence of antibodies

  Day 1 through Day 113

Study Arms (8)

Dosing cohort 1

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 2

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 3

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 4

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 5

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 6

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 7

EXPERIMENTAL

Drug: REGN1154 or placebo

Dosing cohort 8

EXPERIMENTAL

Drug: REGN1154 or placebo

Interventions

REGN1154 or placebo DRUG

Participants will receive active drug or placebo

Dosing cohort 1; Dosing cohort 2; Dosing cohort 3; Dosing cohort 4; Dosing cohort 5; Dosing cohort 6; Dosing cohort 7; Dosing cohort 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
• Able to read or to understand the consent process, and willing to sign the informed consent form (ICF)

You may not qualify if:

• Any illness or condition that would adversely affect the subject's participation in this study
• Any clinically significant abnormalities observed during the screening visit
• Use of certain medications taken before the screening visit
• Onset of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit
• Hospitalization within 60 days of the screening visit
• Any condition that would place the subject at risk, interfere with participation in the study
• History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
• History of certain other conditions
• Positive urine, drug or alcohol screen result at screening
• 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
• Live/attenuated vaccinations within 12 weeks of screening or during the study

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Unknown Facility

Melbourne, Australia

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 28, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 24, 2014

Record last verified: 2013-01

Locations

AU (1)