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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01030640

Enrollment

Registered

2009-12-11

Start date

2009-12-31

Completion date

2010-09-30

Last updated

2011-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

intraepidermal nerve fiber density, IENF, tanezumab, subcutaneous, healthy volunteers

Brief summary

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

Interventions

OTHERplacebo

single dose of the drug formulation

BIOLOGICALtanezumab

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026