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Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

Last updated on December 16, 2017

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

- Healthy male and/or female subjects of non childbearing potential 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 and clinical laboratory tests).

- Female subjects of non childbearing potential must meet at least one of the following
criteria:

1. Achieved postmenopausal status, defined as: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level within the
laboratory's reference range for postmenopausal females;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
females with tubal ligations and females that do NOT have a documented
hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered
to be of childbearing potential.

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

- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legal representative) has been informed of all pertinent aspects of
the study.

- X-ray with no evidence of current, active TB or previous inactive TB, general
infections, heart failure, malignancy, or other clinically significant abnormalities
taken at Screening or within 3 months prior to Day 1 and read by a qualified
radiologist.

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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

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

- Subjects with a history of autoimmune disorders.

- Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.

- History of tuberculosis or active, latent or inadequately treated tuberculosis
infection.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding
the first dose of study medication.

- Pregnant females; breastfeeding females; and females of childbearing potential.

NCT01989143
Pfizer
Completed
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

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Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.
A Phase 1, Randomzied, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Intravenous And Multiple Subcutaneous And Intravenous Doses Of Pf-06480605 In Healthy Subjects
This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06480605
    Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.
  • Drug: Placebo
    Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.
  • Drug: PF-06480605
    Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).
  • Drug: Placebo
    Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
  • Drug: PF-06480605
    Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).
  • Drug: Placebo
    Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
  • Experimental: SAD Cohorts 1-8 Experimental Arm
    Intervention: Drug: PF-06480605
  • Placebo Comparator: SAD Cohorts 1-8 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD Cohorts 9-11 Experimental Arm
    Intervention: Drug: PF-06480605
  • Placebo Comparator: MAD Cohorts 9-11 Placebo Arm
    Intervention: Drug: Placebo
  • Experimental: MAD Cohort 12 Experimental Arm
    Intervention: Drug: PF-06480605
  • Placebo Comparator: MAD Cohort 12 Placebo Arm
    Intervention: 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
92
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential 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 and clinical laboratory tests).
  • Female subjects of non childbearing potential must meet at least one of the following criteria:

    1. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
    2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  • X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
  • Subjects with a history of autoimmune disorders.
  • Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
  • History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding the first dose of study medication.
  • Pregnant females; breastfeeding females; and females of childbearing potential.
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
 
 
NCT01989143
B7541001
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.

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1-800-718-1021

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Contact

[email protected]



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