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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02537002
Enrollment
17
Registered
2015-09-01
Start date
2015-09-30
Completion date
2016-03-31
Last updated
2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PF-05230907, Pharmacokinetics, Pharmacodynamic, Immunogenicity

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

Interventions

DRUGPF-05230907

A single intravenous dose of 3 μg/kg

DRUGPlacebo

A single intravenous dose of matched placebo

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907up to 2 months

Secondary

MeasureTime frame
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Plasma Decay Half-Life (t1/2) of PF-05230907Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose steady state Volume of Distribution (Vss) of PF-05230907Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose clearance (CL) of PF-05230907Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Maximum Observed plasma concentration (Cmax) of PF-05230907Minute 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-05230907Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907Minute 0, 2, 5, 15, 40, 60 minute post-dose
Change of prothrombin fragments 1+2 (PF1+2)Hour 0, 24 hour post-dose
Change of plasma D-dimerHour 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 activityup to 2 months
Change of aPTT from pre-dose to post-doseHour 0, 24 hour post-dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026