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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788294

A4091013

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

10 mg IV

Active Comparator group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

5 mg SC

Active Comparator group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

10 mg SC

Active Comparator group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

19 mg SC

Active Comparator group

Treatment:

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab

Biological: tanezumab