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

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

Official Title
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A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers

Conditions
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Osteoarthritis Pain, Chronic Low Back Pain, Pain Due to Interstitial Cystitis

Intervention / Treatment
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* Other: placebo
* Biological: tanezumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>formulation without active drug | Other: placebo<br>* single dose of the drug formulation<br>|
| Active Comparator: tanezumab<br> | Biological: tanezumab<br>* single dose of the active drug tanezumab at a dose level of 20 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraepidermal nerve fiber density, IENF, tanezumab, subcutaneous, healthy volunteers