Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
1 other identifier
interventional
76
1 country
1
Brief Summary
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Nov 2008
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 6, 2020
July 1, 2009
7 months
November 7, 2008
October 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Subcutaneous bioavailability
16 weeks
Injection site reactions
16 weeks
Immunogenicity
16 weeks
Secondary Outcomes (1)
Nerve growth factor levels
16 weeks
Study Arms (4)
10 mg IV
ACTIVE COMPARATOR5 mg SC
ACTIVE COMPARATOR10 mg SC
ACTIVE COMPARATOR19 mg SC
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Generally healthy
- BMI of 18-30 kg/m2
- more than 50 kg bodyweight.
You may not qualify if:
- Pregnant
- exposure to biologic type drugs within the last 3 months
- history of allergic or anaphylactic reaction to a biologic drug
- use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
- excessive alcohol use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Cypress, California, 90630, 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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
November 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
October 6, 2020
Record last verified: 2009-07