Single Dose Study of PF-05230907 in Healthy Japanese Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-05230907; Drug: PF-05230907; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511-5473
      • Pfizer New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1- PF-05230907 or Placebo	Drug: PF-05230907; A single intravenous dose of 3 μg/kg; Drug: PF-05230907; A single intravenous dose of 5 μg/kg; Drug: Placebo; A single intravenous dose of matched placebo
Experimental: Cohort 2- PF-05230907 or Placebo	Drug: PF-05230907; A single intravenous dose of 3 μg/kg; Drug: PF-05230907; A single intravenous dose of 5 μg/kg; Drug: Placebo; A single intravenous dose of matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907	up to 2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of development of anti-drug antibody (ADA)	up to 2 months
Incidence of development of neutralizing antibody (NAb)	up to 2 months
Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Plasma Decay Half-Life (t1/2) of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose steady state Volume of Distribution (Vss) of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose clearance (CL) of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907	Minute 0, 2, 5, 15, 40, 60 minute post-dose
Change of aPTT from pre-dose to post-dose	Hour 0, 24 hour post-dose
Change of prothrombin fragments 1+2 (PF1+2)	Hour 0, 24 hour post-dose
Change of plasma D-dimer	Hour 0, 48 hour post-dose
Change of factor X activity	up to 2 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: August 28, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Estimate): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 28, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Immunogenicity; Pharmacodynamic; PF-05230907
• Other Study ID Numbers: B2341003