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OpenTrials
Completed

NCT Number: NCT00788294

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tanezumab

Biological

Drug solution given intravenously only once at dose of 10 mg

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 10, 2008
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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