Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Pfizer17 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-05230907DRUG

A single intravenous dose of 3 μg/kg

PF-05230907DRUG

A single intravenous dose of 5 μg/kg

PlaceboDRUG

A single intravenous dose of matched placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907

Time frame: up to 2 months