A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01897142

Enrollment

Registered

2013-07-11

Start date

2013-09-30

Completion date

2015-03-31

Last updated

2016-04-22

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

Conditions

Healthy

Brief summary

The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

Interventions

BIOLOGICALPF-05230907

0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose

DRUGPlacebo for PF-05230907

0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Study design

Allocation

RANDOMIZED

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects. * Healthy non-child bearing female subjects. * 18 to 35 years of age.

Exclusion criteria

* Heart disease. * Clotting disorders. * Use of nicotine products. * Diabetes.

Design outcomes

Primary

Measure	Time frame
Incidence of dose limiting treatment related adverse events	Through Day 43
Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events	Through Day 43
Incidence and magnitude of treatment emergent abnormal laboratory findings	Through Day 43
Change from baseline in vital sign measurements, ECG parameters, and physical examinations	Through Day 43

Secondary

Measure	Time frame
Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes	Through post dose Day 2
Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2)	Through post dose Day 2
Pharmacodynamic activity as measured by D-dimer	Through post dose Day 7
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Through 4 hour post dose Day 1
Pharmacodynamic activity as measured by Factor V activity	Through post dose Day 3
Incidence of antibody immune response	Through post dose Day 43
Factor X activity	Through post dose Day 43
Pharmacodynamic activity as measured by protein C activity	Through post dose Day 2
Maximum Observed Plasma Concentration (Cmax)	Through 4 hour post dose Day 1
Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR)	Through post dose Day3
Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)	Through post dose Day3

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026