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
1 other identifier
interventional
28
1 country
2
Brief Summary
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 26, 2011
April 1, 2011
9 months
December 9, 2009
April 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
16 weeks
Study Arms (2)
placebo
PLACEBO COMPARATORformulation without active drug
tanezumab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 11, 2009
Study Start
December 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 26, 2011
Record last verified: 2011-04