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

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NCT01740609

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01740609
Pfizer
Completed
A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

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[email protected]

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A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
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
 
 
NCT01740609
B4351001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

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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