Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234

NCT02711462

Last updated date
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234
Official Title  ICMJE A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects
Brief Summary

This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study.

Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated.

A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06687234
    PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
    Other Name: Dekavil
  • Drug: Placebo
    In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.
Study Arms  ICMJE
  • Cohort 1
    Subjects will receive 2mg of PF 06687234 or placebo via the SC route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 2
    Subjects will receive 20mg PF 06687234 or placebo via the SC route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 3
    This is an optional cohort that may be added anytime during the study. In this cohort, subjects will receive PF 06687234 or placebo via the SC route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 4
    Subjects will receive 40mg of PF 06687234 or placebo via the SC route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 5
    Subjects will receive 80mg of PF 06687234 or placebo via the SC route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 6
    Subjects receive a single dose of PF 06687234 or placebo via the IV route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 7
    This is an optional cohort where Japanese subjects will receive PF 06687234 or placebo via the SC route
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 8
    Subjects in this cohort may receive 20 mg of PF 06687234 or placebo via the SC route every week with a total of 5 doses
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 9
    Subjects in this cohort may receive 40 mg of PF 06687234 or placebo via the SC route every two weeks with a total of 3 doses
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 10
    This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
  • Cohort 11
    This is an optional cohort. The maximum dose tested in the multiple dose cohort will not exceed the highest dose tested in the single dose cohorts
    Interventions:
    • Drug: PF-06687234
    • Drug: Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2016)
82
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  • Healthy females of non childbearing potential and healthy males
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  • Ability to personally sign and date the informed consent document and able to comply with schedule of activities
  • For Single Dose Cohort 7 only, Japanese subjects must have four biological Japanese grandparents born in Japan.

EXCLUSION CRITERIA

  • Evidence or history of clinically significant health concerns
  • Treatment with an investigational drug within 30 days
  • Exposure to any live vaccines within 28 days prior to investigational product administration.
  • History of drug and/ or alcohol abuse and tobacco use equivalent of 5 cigarettes per day.
  • Known history of infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
  • Pregnant female subjects
  • History of sensitivity to heparin
  • Unwilling or unable to comply with the Lifestyle Guidelines as stated in the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02711462
Other Study ID Numbers  ICMJE B7581001
2015-000710-22 ( EudraCT Number )
DEKAVIL ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Principal Investigator:Laure Mendes da CostaPfizer Clinical Research Unit
PRS Account Pfizer
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP