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A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer 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.
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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 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 oral temperature, blood pressure (BP) and pulse rate
(PR) measurement, 12 lead ECG or clinical laboratory tests

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

1. Achieved postmenopausal status, defined as follows: 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
confirming the post menopausal state;

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) will be considered to be of childbearing potential

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

- Chest X ray with no evidence of current, active tuberculosis (TB) or previous inactive
TB, general infections, heart failure, malignancy, or other clinically significant
abnormalities taken at Screening or within 3 months prior to Screening 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 the time of dosing).

- Subjects with a history of autoimmune disorders (including but not limited to: Crohn's
Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's
disease) and other conditions that compromise or impair the immune system

- Subjects with a history of allergic or anaphylactic reaction to any drug including
immunoglobulin

- History of active infections within 28 days prior to the screening visit

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

- Subjects with a history of thromboembolic events or current positive result for
anti-cardiolipin antibody

- History of TB or active, latent or inadequately treated TB infection. All positive TB
test result(s) are exclusionary

- Male subjects with partners currently pregnant; male subjects able to father children
who are unwilling or unable to use a highly effective method of contraception as
outlined in this protocol for the duration of the study.

NCT03275740
Pfizer
Active, not recruiting
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

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A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, First-in-human Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06755347 After Single Ascending Intravenous Infusions To Healthy Adult Subjects
This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult subjects. The pharmacokinetics and pharmacodynamics will also be evaluated.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single ascending dose study

Masking: Double (Participant, Investigator)
Masking Description:

Double blind (investigator and subject), sponsor open

Primary Purpose: Treatment

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
  • Drug: PF-06755347
    Single doses of PF-06755347 will be administered, at planned dose levels of 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 7.5 mg/kg, 15 mg/kg, 30 mg/kg, and 45 mg/kg.
  • Drug: Placebo comparator
    Placebo comparator
  • Experimental: PF-06755347
    Intervention: Drug: PF-06755347
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo comparator
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
December 30, 2018
December 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential 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 oral temperature, blood pressure (BP) and pulse rate (PR) measurement, 12 lead ECG or clinical laboratory tests
  • Female subjects of non childbearing potential must meet at least one of the following criteria:

    1. Achieved postmenopausal status, defined as follows: 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 confirming the post menopausal state;
    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) will be considered to be of childbearing potential
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Chest X ray with no evidence of current, active tuberculosis (TB) or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Screening 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 the time of dosing).
  • Subjects with a history of autoimmune disorders (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease) and other conditions that compromise or impair the immune system
  • Subjects with a history of allergic or anaphylactic reaction to any drug including immunoglobulin
  • History of active infections within 28 days prior to the screening visit
  • Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HepBsAg), Hepatitis B core antibody (HepBcAb), Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
  • Subjects with a history of thromboembolic events or current positive result for anti-cardiolipin antibody
  • History of TB or active, latent or inadequately treated TB infection. All positive TB test result(s) are exclusionary
  • Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.
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
 
 
NCT03275740
B7801001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Noam Epstein, MD Pfizer
Pfizer
December 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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