Clinical trial NCT02537002: Single Dose Study of PF-05230907 in Healthy Japanese Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-05230907
Pharmacokinetics
Pharmacodynamic
Immunogenicity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
timeFrame: up to 2 months
Secondary outcomes:
measure: Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Single dose Plasma Decay Half-Life (t1/2) of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Single dose steady state Volume of Distribution (Vss) of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Single dose clearance (CL) of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Single dose Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (last)]of PF-05230907
timeFrame: Minute 0, 2, 5, 15, 40, 60 minute post-dose
measure: Change of aPTT from pre-dose to post-dose
timeFrame: Hour 0, 24 hour post-dose
measure: Change of prothrombin fragments 1+2 (PF1+2)
timeFrame: Hour 0, 24 hour post-dose
measure: Change of plasma D-dimer
timeFrame: Hour 0, 48 hour post-dose
measure: Incidence of development of anti-drug antibody (ADA)
timeFrame: up to 2 months
measure: Incidence of development of neutralizing antibody (NAb)
timeFrame: up to 2 months
measure: Change of factor X activity
timeFrame: up to 2 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: