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

Pfizer28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis Pain Chronic Low Back Pain Pain Due to Interstitial Cystitis

Interventions

placeboOTHER

single dose of the drug formulation

tanezumabBIOLOGICAL

single dose of the active drug tanezumab at a dose level of 20 mg

Eligibility

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

Medical Language ↔ Plain English

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

Locations (2)

Pfizer Investigational Site

Overland Park, Kansas, United States

Pfizer Investigational Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 16 weeks

To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.

Time frame: 16 weeks

Secondary Outcomes

To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers

Time frame: 16 weeks

Data from ClinicalTrials.gov

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