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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00788294

Enrollment

Registered

2008-11-10

Start date

2008-11-30

Completion date

2009-06-30

Last updated

2020-10-06

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

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects

Brief summary

The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.

Interventions

BIOLOGICALtanezumab

Drug solution given intravenously only once at dose of 10 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Generally healthy * BMI of 18-30 kg/m2 * more than 50 kg bodyweight.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Subcutaneous bioavailability	16 weeks
Injection site reactions	16 weeks
Immunogenicity	16 weeks

Secondary

Measure	Time frame
Nerve growth factor levels	16 weeks

Countries

United States

Outcome results

None listed

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