Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05230907; Drug: Placebo

• Registration Number: NCT02537002
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-09
• Study First Posted: 2015-09-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1- PF-05230907 or Placebo	PF-05230907	-
Cohort 1- PF-05230907 or Placebo	Placebo	-
Cohort 2- PF-05230907 or Placebo	PF-05230907	-
Cohort 2- PF-05230907 or Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907	up to 2 months

Secondary Outcome Measures

Name	Time	Method
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
Incidence of development of anti-drug antibody (ADA)	up to 2 months
Incidence of development of neutralizing antibody (NAb)	up to 2 months
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 Plasma Decay Half-Life (t1/2) 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 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
Single dose steady state Volume of Distribution (Vss) 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
Change of factor X activity	up to 2 months

Trial Locations

Locations (1)

Pfizer New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States