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

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893528
• Other study ID #: R2009-HV-1304
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2013
• Last updated: November 7, 2014
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN2009

Other:
• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes