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

Last updated on October 10, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
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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Descriptive Information
Brief Title  ICMJE A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
Official Title  ICMJE 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 MALE PARTICIPANTS
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
single ascending dose study

Masking: Double (Participant, Investigator)
Masking Description:

Double blind (investigator and subject), sponsor open

Primary Purpose: Treatment

Condition  ICMJE
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
  • Idiopathic Thrombocytopenic Purpura
Intervention  ICMJE
  • Drug: PF-06755347
    Single doses of PF-06755347 will be administered, at planned dose levels of 0.01 mg/kg, 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 7.5 mg/kg, 15 mg/kg, and 30 mg/kg.
  • Drug: Placebo comparator
    Placebo comparator
Study Arms  ICMJE
  • Experimental: PF-06755347
    Intervention: Drug: PF-06755347
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo comparator
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
64
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2017)
73
Estimated Study Completion Date  ICMJE September 21, 2020
Estimated Primary Completion DateSeptember 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male participants who, at the time of screening, are between the ages of 18 and 40 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 measurement, pulse oximetry, 12 lead ECG or clinical laboratory tests.
  • 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).
  • Participants with a history of autoimmune disorders and other conditions that compromise or impair the immune system (including but not limited to: Crohns Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves disease, and asthma) or have a current positive result for the following; rheumatoid factor, anti-nuclear antibody, or abnormal free triiodothyronine (T3), free thyroxine (T4), thyroid stimulating hormone (TSH), or thyroid stimulating antibody (TSAb) suggestive of thyroid disease.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Belgium
Removed Location CountriesUnited States
 
Administrative Information
NCT Number  ICMJE NCT03275740
Other Study ID Numbers  ICMJE B7801001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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