Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers

NCT01893528 | Completed Phase 1

• 1 other identifier: R2009-HV-1304
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of TEAEs

  The primary endpoint in this study is the incidence and severity of Treatment Emergent Adverse Events (TEAEs) in healthy volunteers treated with REGN2009 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 15.

  day 1 to day 106/ visit 15

Study Arms (3)

REGN2009 dose level 1

EXPERIMENTAL

Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Drug: REGN2009; Other: placebo

REGN2009 dose level 2

EXPERIMENTAL

Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Drug: REGN2009; Other: placebo

REGN2009 dose level 3

EXPERIMENTAL

Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Drug: REGN2009; Other: placebo

Interventions

REGN2009 DRUG

REGN2009 dose level 1; REGN2009 dose level 2; REGN2009 dose level 3

placebo OTHER

REGN2009 dose level 1; REGN2009 dose level 2; REGN2009 dose level 3

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 ages 18 to 65 years inclusive
• Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive

You may not qualify if:

• Pregnant or breast-feeding women
• Any clinically significant abnormalities observed during screening (day -21 to day -2)
• Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
• History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
• Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
• Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
• History of a hypersensitivity reaction to doxycycline or similar compound
• Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
• Previous adverse experience to any biological investigational or therapeutic agent
• Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2013
• First Posted: July 9, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

US (2)