Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers

NCT01197391 | Completed Phase 1

• 1 other identifier: R728-CL-0915
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN728 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by subcutaneous injection (under the skin) at the clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, blood and urine samples will be collected at some or all visits.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The primary endpoint in the study is the percentage of subjects with treatment emergent adverse events, reported from the administration of study drug on day 1 to the completion of the study on day 106.

  106 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Dose 1 versus placebo

Biological: REGN728

Cohort 2

EXPERIMENTAL

Dose 2 versus placebo

Biological: REGN728

Interventions

REGN728 BIOLOGICAL

2 Subcutaneous Cohorts (dose 1, 2)

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Male or female 18 to 65 years of age.
• Weight\> 50 kg and \<95 kg inclusive
• For men of childbearing potential, willingness to utilize adequate contraception and not have their partner\[s\] become pregnant during the full duration of the study.
• Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
• Able to read, understand and willing to sign the informed consent form.

You may not qualify if:

• Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to screening visit.
• Women of childbearing potential, pregnant and breast-feeding women are excluded. Women are considered to be of childbearing potential until they have been amenorrheic for at least 12 months or have had surgical sterilization.
• 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 would adversely affect the subject's participation in this study.
• Hospitalization for any reason within 60 days of screening.
• 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.
• Previous exposure to any therapeutic or investigational biological agent.
• History of alcohol or substance abuse within a year prior to the screening visit.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (2)

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: September 9, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

US (2)