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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484600
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Healthy Drug: REGN668: Injection Rate 1 Drug: REGN668: Injection Rate 2 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline through day 64 (end of study) ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) profile of REGN668 [ Time Frame: Baseline through day 64 ]
  2. Incidence of anti-REGN668 antibodies [ Time Frame: Day 29 and Day 64 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01484600

United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01484600     History of Changes
Other Study ID Numbers: R668-HV-1108
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012

Keywords provided by Regeneron Pharmaceuticals: