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

October 2, 2020 updated by: Pfizer

Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10 mg IV
Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.
Active Comparator: 5 mg SC
Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.
Active Comparator: 10 mg SC
Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.
Active Comparator: 19 mg SC
Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subcutaneous bioavailability
Time Frame: 16 weeks
16 weeks
Injection site reactions
Time Frame: 16 weeks
16 weeks
Immunogenicity
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Nerve growth factor levels
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (Estimate)

November 10, 2008

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4091013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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