Single Dose Study of PF-05230907 in Healthy Japanese Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:4/22/2016
Start Date:September 2015
End Date:March 2016

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of An Intravenous Bolus Infusion Pf-05230907 In Healthy Japanese Subjects

The purpose of this study is the following:

- To determine the safety and tolerability of single ascending intravenous (IV) doses of
PF-05230907 in healthy Japanese subjects.

- To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy
Japanese subjects.

- To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy
Japanese subjects.

- To evaluate the immunogenicity of PF-05230907 in healthy Japanese subjects


Inclusion Criteria:

- Healthy male of females

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
and <120 kg (265 lbs).

- Japanese subjects who have four biologic Japanese grandparents born in Japan.

Exclusion Criteria:

- Pregnant or nursing females.

- Females of childbearing potential who are unwilling or unable to use an acceptable
method of contraception.

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease
We found this trial at
1
site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut 06511
?
mi
from
New Haven, CT
Click here to add this to my saved trials