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

Pfizer1 site in 1 country17 target enrollmentSeptember 2015

ConditionsHealthy

InterventionsPF-05230907 Placebo

DrugsPF-05230907 Placebo

Overview

Phase: Phase 1
Intervention: PF-05230907
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 17
Locations: 1
Primary Endpoint: Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

March 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Cohort 1- PF-05230907 or Placebo

Intervention: PF-05230907

Cohort 1- PF-05230907 or Placebo

Intervention: Placebo

Cohort 2- PF-05230907 or Placebo

Intervention: PF-05230907

Cohort 2- PF-05230907 or Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: up to 2 months

Secondary Outcomes

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)
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 Plasma Decay Half-Life (t1/2) 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 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)
Single dose steady state Volume of Distribution (Vss) 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)
Change of factor X activity(up to 2 months)