Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01484600
First received: November 30, 2011
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

This is a study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN668 Administered Subcutaneously to Healthy Volunteers.


Condition Intervention Phase
Healthy
Drug: REGN668: Injection Rate 1
Drug: REGN668: Injection Rate 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline through day 64 (end of study) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) profile of REGN668 [ Time Frame: Baseline through day 64 ] [ Designated as safety issue: No ]
  • Incidence of anti-REGN668 antibodies [ Time Frame: Day 29 and Day 64 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Drug: REGN668: Injection Rate 1
Subjects will receive REGN668 via SC injection
Experimental: Group 2 Drug: REGN668: Injection Rate 2
Subjects will receive study drug via alternate delivery (if necessary)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects 18 to 55 years of age.
  2. Body weight between 60 kg and 80 kg, body mass index between 20 and 30 kg/m2 inclusive.
  3. NHV as evidenced by comprehensive clinical assessment (detailed medical history and complete physical examination).
  4. Normal resting blood pressure and heart rate
  5. Willingness to refrain from the consumption of alcohol for 24 hours prior to each study visit.

Exclusion Criteria:

  1. History or presence of currently relevant medical conditions, including any cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, psychiatric, systemic, ocular, infectious or parasitic disease, or signs of acute illness.
  2. Administration of any medications within 1 week before randomization, other than vitamins, nutritional supplements, or low doses of aspirin taken prophylactically.
  3. Onset of a new exercise routine or major change to a previous exercise routine within 2 weeks prior to randomization. Subjects must be willing to maintain a relatively constant level of exercise during the study and refrain from unusually strenuous physical activities
  4. 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.
  5. History of substance (eg. drug or alcohol) abuse or regular (daily) smoking within a year prior to randomization or positive results on urine drug screen.
  6. Excessive consumption of beverages with xanthine derivates (caffeine, theophylline, theobromine), such as coffee, tea, cola, or yerba mate (more than 4 cups or glasses per day).
  7. Hospitalization for any reason within 60 days of randomization.
  8. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of the investigational drug, whichever is longer, prior to the randomization visit.
  9. Live/attenuated vaccinations within 12 weeks of randomization or during the study.
  10. Tuberculosis vaccination within the last year.
  11. Previous exposure to any other biological agent within 12 months of randomization.
  12. History of a hypersensitivity reaction to doxycycline or other tetracyclines.
  13. Recent travel (within 12 months of randomization) to areas endemic for parasitic helminthes, such as developing countries, particularly in Africa and the tropical and subtropical regions of Asia.
  14. Pregnant or breast-feeding women.
  15. Unwilling to use adequate birth control if of reproductive potential and sexually active
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484600

Locations
United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01484600     History of Changes
Other Study ID Numbers: R668-HV-1108
Study First Received: November 30, 2011
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Regeneron Pharmaceuticals:
Volunteers

ClinicalTrials.gov processed this record on April 17, 2014