Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: PF-05230907

Study type

Interventional

Funder types

Industry

Identifiers

B2341003

Details and patient eligibility

About

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

Enrollment

17 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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