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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: tanezumab

• Registration Number: NCT00788294
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mg SC	tanezumab	-
19 mg SC	tanezumab	-
5 mg SC	tanezumab	-
10 mg IV	tanezumab	-

Primary Outcome Measures

Name	Time	Method
Subcutaneous bioavailability	16 weeks
Immunogenicity	16 weeks
Injection site reactions	16 weeks

Secondary Outcome Measures

Name	Time	Method
Nerve growth factor levels	16 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Cypress, California, United States