Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-05230907
* Drug: PF-05230907
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of development of anti-drug antibody (ADA) |  | up to 2 months | 
| Incidence of development of neutralizing antibody (NAb) |  | up to 2 months | 
| Change of factor X activity |  | up to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-05230907, Pharmacokinetics, Pharmacodynamic, Immunogenicity