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Single Dose Study of PF-05230907 in Healthy Japanese Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511-5473 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Japanese subjects who have four biologic Japanese grandparents born in Japan.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02537002
Pfizer
Completed
Single Dose Study of PF-05230907 in Healthy Japanese Subjects

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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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05230907
    A single intravenous dose of 3 ?g/kg
  • Drug: PF-05230907
    A single intravenous dose of 5 ?g/kg
  • Drug: Placebo
    A single intravenous dose of matched placebo
  • Experimental: Cohort 1- PF-05230907 or Placebo
    Interventions:
    • Drug: PF-05230907
    • Drug: Placebo
  • Experimental: Cohort 2- PF-05230907 or Placebo
    Interventions:
    • Drug: PF-05230907
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
March 2016
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02537002
B2341003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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