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CompletedNCT00788294Updated Oct 6, 2020

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

A Phase 1 interventional study of tanezumab and tanezumab in Healthy Volunteers, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-06.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2009, 17 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    10 mg IV

    Biological: tanezumab

  • Active comparator
    5 mg SC

    Biological: tanezumab

  • Active comparator
    10 mg SC

    Biological: tanezumab

  • Active comparator
    19 mg SC

    Biological: tanezumab

Interventions

  • Biologicaltanezumab

    Drug solution given intravenously only once at dose of 10 mg

  • Biologicaltanezumab

    Drug solution given subcutaneously only once at dose of 5 mg.

  • Biologicaltanezumab

    Drug solution given subcutaneously only once at dose of 10 mg.

  • Biologicaltanezumab

    Drug solution given subcutaneously only once at dose of 19 mg.

06

What researchers measure

Primary outcomes

  1. Subcutaneous bioavailability

    Time frame: 16 weeks

  2. Injection site reactions

    Time frame: 16 weeks

  3. Immunogenicity

    Time frame: 16 weeks

Secondary outcomes

  1. Nerve growth factor levels

    Time frame: 16 weeks

07

Study locations

1 site
  • Pfizer Investigational Site
    Cypress, California 90630, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00788294
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 10, 2008
Start date
Nov 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Oct 6, 2020

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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