Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: November 7, 2008
Last updated: July 14, 2009
Last verified: July 2009

The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.

Condition Intervention Phase
Healthy Volunteers
Biological: tanezumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Subcutaneous bioavailability [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Injection site reactions [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Immunogenicity [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nerve growth factor levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 mg IV Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
Active Comparator: 5 mg SC Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
Active Comparator: 10 mg SC Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
Active Comparator: 19 mg SC Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.


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

Inclusion Criteria:

  • Generally healthy
  • BMI of 18-30 kg/m2
  • more than 50 kg bodyweight.

Exclusion Criteria:

  • Pregnant
  • exposure to biologic type drugs within the last 3 months
  • history of allergic or anaphylactic reaction to a biologic drug
  • use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
  • excessive alcohol use.
  Contacts and Locations
Please refer to this study by its identifier: NCT00788294

United States, California
Pfizer Investigational Site
Cypress, California, United States, 90630
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00788294     History of Changes
Other Study ID Numbers: A4091013
Study First Received: November 7, 2008
Last Updated: July 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects processed this record on April 17, 2014