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

Pfizer76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

tanezumabBIOLOGICAL

Drug solution given intravenously only once at dose of 10 mg

tanezumabBIOLOGICAL

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

tanezumabBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Cypress, California, United States

Outcomes

Primary Outcomes

Subcutaneous bioavailability

Time frame: 16 weeks

Injection site reactions

Time frame: 16 weeks

Immunogenicity

Time frame: 16 weeks

Secondary Outcomes

Nerve growth factor levels

Time frame: 16 weeks

Data from ClinicalTrials.gov

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