An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193

Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: REGN1193

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy men and women 18 to 45 years of age (inclusive)
2. Body mass index 18.0 to 30.0 kg/m^2 (inclusive)
3. Normal standard 12-lead ECG
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. For sexually active men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during and for up to 3 months after participation in the study.

Exclusion Criteria:

1. Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
2. History of drug or alcohol abuse within a year prior to the screening visit
3. Current regular smoking, or a history of smoking greater than ½ pack
4. Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subject's participation in this study
6. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
7. Hospitalization for any reason within 60 days of screening
8. History or presence of malignancy (including carcinoma in situ) prior to the screening visit
9. Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
10. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants in Group A will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo.	Other: Placebo; Drug: REGN1193
Experimental: Group B; Participants in Group B will consist of up to 6 sequential ascending dose cohorts. Each cohort will therefore receive 1 of 6 ascending dosing levels of the study drug (REGN1193) or placebo.	Other: Placebo; Drug: REGN1193

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of TEAEs	The primary endpoint in this study is the incidence and severity of TEAEs (treatment emergent adverse events) in healthy volunteers treated with REGN1193 or placebo reported from day 1 (baseline) to the completion of the study on day 106/ visit 16.	day 1 to day 106

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration	Serum concentrations of REGN1193 over time	day 1 to day 106

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Estimate): March 13, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: R1193-HV-1219