A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

NCT01740609

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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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
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.

- BMI between 18.5 to 32 kg/m2.

- Total body weight ≥40 kg and ≤120 kg.

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


- Previous treatment with an antibody within 6 months prior to Day 1.


- Pregnant or nursing females; females of childbearing potential.


- History of sensitivity to heparin or heparin-induced thrombocytopenia.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
Official Title  ICMJE A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
Brief Summary The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
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: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Biological: PF-06342674 Dose A
    Single SC Dose
  • Biological: PF-06342674 Dose B
    Single SC Dose
  • Biological: PF-06342674 Dose C
    Single SC Dose
  • Biological: PF-06342674 Dose D
    Single SC Dose
  • Biological: PF-06342674 Dose E
    Single SC Dose
  • Biological: PF-06342674 Dose F
    Single IV Dose
  • Biological: PF-06342674 Dose G
    Single SC Dose
  • Biological: PF-06342674 Dose H
    Single IV Dose
  • Biological: PF-06342674 Dose I
    Single SC Dose
  • Biological: PF-06342674 Dose J
    Single IV Dose
Study Arms  ICMJE
  • Placebo Comparator: 1. Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2.0
    Interventions:
    • Biological: PF-06342674 Dose A
    • Biological: PF-06342674 Dose B
    • Biological: PF-06342674 Dose C
    • Biological: PF-06342674 Dose D
    • Biological: PF-06342674 Dose E
    • Biological: PF-06342674 Dose F
    • Biological: PF-06342674 Dose G
    • Biological: PF-06342674 Dose H
    • Biological: PF-06342674 Dose I
    • Biological: PF-06342674 Dose J
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2014)
80
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
76
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
  • BMI between 18.5 to 32 kg/m2.
  • Total body weight ?40 kg and ?120 kg.

Exclusion Criteria:

  • Previous treatment with an antibody within 6 months prior to Day 1.
  • Pregnant or nursing females; females of childbearing potential.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740609
Other Study ID Numbers  ICMJE B4351001
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
PRS Account Pfizer
Verification Date June 2014

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