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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: REGN2009; Other: placebo

• Registration Number: NCT01893528
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-21
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-07
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Healthy men and women ages 18 to 65 years inclusive
2. Body mass index between 18.0 kg/m^2 and 30.0 kg/m^2, inclusive

Exclusion Criteria

1. Pregnant or breast-feeding women
2. Any clinically significant abnormalities observed during screening (day -21 to day -2)
3. 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
4. History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
5. Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
6. 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)
7. History of a hypersensitivity reaction to doxycycline or similar compound
8. 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
9. Previous adverse experience to any biological investigational or therapeutic agent
10. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REGN2009 dose level 1	REGN2009	Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
REGN2009 dose level 3	REGN2009	Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
REGN2009 dose level 2	REGN2009	Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
REGN2009 dose level 2	placebo	Cohort C - REGN2009 or placebo; Cohort D - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
REGN2009 dose level 3	placebo	Cohort E - REGN2009 or placebo; Cohort F - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)
REGN2009 dose level 1	placebo	Cohort A - REGN2009 or placebo; Cohort B - Patients on existing (non-exclusionary) medications + (REGN2009 or placebo)

Primary Outcome Measures

Name	Time	Method
Number of TEAEs	day 1 to day 106/ visit 15	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.