NCT02537002

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2015

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

August 28, 2015

Last Update Submit

April 28, 2016

Conditions

Healthy

Keywords

PF-05230907PharmacokineticsPharmacodynamicImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907

    up to 2 months

Secondary Outcomes (13)

  • 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 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

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

    Minute 0, 2, 5, 15, 40, 60 minute 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 clearance (CL) of PF-05230907

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

  • +8 more secondary outcomes

Study Arms (2)

Cohort 1- PF-05230907 or Placebo

EXPERIMENTAL
Drug: PF-05230907Drug: Placebo

Cohort 2- PF-05230907 or Placebo

EXPERIMENTAL
Drug: PF-05230907Drug: Placebo

Interventions

PF-05230907DRUG

A single intravenous dose of 3 μg/kg

Cohort 1- PF-05230907 or Placebo
PlaceboDRUG

A single intravenous dose of matched placebo

Cohort 1- PF-05230907 or PlaceboCohort 2- PF-05230907 or Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

MeSH Terms

Interventions

PF-05230907

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 1, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

US(1)