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Completed

NCT Number: NCT02537002

Single Dose Study of 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

Completed

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511-5473, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-05230907

Drug

A single intravenous dose of 3 μg/kg

Placebo

Drug

A single intravenous dose of matched placebo

Primary outcomes

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

    Time frame: up to 2 months

Secondary outcomes

  1. Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  2. Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  3. Single dose Plasma Decay Half-Life (t1/2) of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  4. Single dose steady state Volume of Distribution (Vss) of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  5. Single dose clearance (CL) of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  6. Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  7. Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907

    Time frame: Minute 0, 2, 5, 15, 40, 60 minute post-dose

  8. Change of aPTT from pre-dose to post-dose

    Time frame: Hour 0, 24 hour post-dose

  9. Change of prothrombin fragments 1+2 (PF1+2)

    Time frame: Hour 0, 24 hour post-dose

  10. Change of plasma D-dimer

    Time frame: Hour 0, 48 hour post-dose

  11. Incidence of development of anti-drug antibody (ADA)

    Time frame: up to 2 months

  12. Incidence of development of neutralizing antibody (NAb)

    Time frame: up to 2 months

  13. Change of factor X activity

    Time frame: up to 2 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2015
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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