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

Last updated on December 14, 2017

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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A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
August 2014
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01616277
B5161001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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