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Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
18002546398
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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy female subjects of non childbearing potential and male subjects who, at the
time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG or clinical laboratory tests.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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

1. History of active or latent tuberculosis (TB) regardless of treatment; positive
Quantiferon - TB test.

2. Subjects with a history of autoimmune disorders.

3. Subjects with a history of or positive results for any of the following serological
tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti
Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).

NCT02766621
Pfizer
Completed
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

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Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
Phase 1, Randomized, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of Pf-06823859 In Healthy Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Biological: PF-06823859
    Comparison of different dosages of PF-06823859 to placebo
    Other Name: Study drug
  • Drug: Placebo injection SC/IV
    Comparison of Placebo to different doses of PF-06823859
    Other Name: Placebo
  • Placebo Comparator: Placebo injection SC/IV
    Placebo for injection SC/IV
    Intervention: Drug: Placebo injection SC/IV
  • Active Comparator: PF-06823859
    Study Drug being used in the study
    Intervention: Biological: PF-06823859
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 26, 2017
August 30, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
  2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  1. History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
  2. Subjects with a history of autoimmune disorders.
  3. Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02766621
C0251001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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.

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