Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected

April 22, 2011 updated by: Pfizer

A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers

Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

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
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66212
        • 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:

  • Healthy subjects only
  • Female subjects can not be pregnant or be nursing.
  • Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
  • Can not have any problematic skin condition.
  • Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
formulation without active drug
Other: placebo
single dose of the drug formulation
ACTIVE_COMPARATOR: tanezumab
Biological: tanezumab
single dose of the active drug tanezumab at a dose level of 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
Time Frame: 16 weeks
16 weeks
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
Time Frame: 16 weeks
16 weeks
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
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

December 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 10, 2009

First Posted (ESTIMATE)

December 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2011

Last Update Submitted That Met QC Criteria

April 22, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4091046

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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