Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected

Phase 1

Completed

• Conditions: Osteoarthritis Pain; Chronic Low Back Pain; Pain Due to Interstitial Cystitis
• Interventions: Other: placebo; Biological: tanezumab

• Registration Number: NCT01030640
• Lead Sponsor: Pfizer

Brief Summary

Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-22
• Last Update Posted: 2011-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Healthy subjects only
• Female subjects can not be pregnant or be nursing.
• Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

• Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
• Can not have any problematic skin condition.
• Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	formulation without active drug
tanezumab	tanezumab	-

Primary Outcome Measures

Name	Time	Method
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.	16 weeks
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.	16 weeks
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.	16 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers	16 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States