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A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects

Last updated on December 12, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
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.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the
ages of 18 and 55 years, inclusive.

- Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the
ages of 18 and less than 65 years, inclusive.

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

- Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).

- Weight loss or gain of >5% within 30 days of Screening, as reported by subject.

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
immunologic, metabolic urologic, dermatologic, renal, allergic disease (including
drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of
dosing) and any other major disease.

NCT01616277
Pfizer
Completed
A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects

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Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
Brief Summary The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
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
  • Biological: PF-06252616
    1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Drug: Placebo
    Placebo for PF-06252616, IV infusion, single dose
  • Biological: PF-06252616
    3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Biological: PF-06252161
    10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Biological: PF-06252616
    3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
  • Drug: Placebo
    Placebo for PF-06252616, Subcutaneous injection, single dose
  • Biological: PF-06252616
    10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
  • Drug: Placebo
    Placebo for PF-06252616, IV infusion, repeat dose
  • Biological: PF-06252616
    20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
  • Biological: PF-06252616
    40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
Study Arms  ICMJE
  • Placebo Comparator: 1
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 2
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 3
    Interventions:
    • Biological: PF-06252161
    • Drug: Placebo
  • Placebo Comparator: 4
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 5
    Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 6
    Interventions:
    • Biological: PF-06252616
    • Drug: Placebo
  • Placebo Comparator: 7
    Interventions:
    • Biological: PF-06252616
    • 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 Completed
Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2012)
63
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
  • Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.

Exclusion Criteria:

  • Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
  • Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 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 NCT01616277
Other Study ID Numbers  ICMJE B5161001
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 Center Pfizer
PRS Account Pfizer
Verification Date September 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

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