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Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People

Last updated on November 21, 2019

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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
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Females of non-childbearing potential

- Body mass index between 17.5 to 30.5 and body weight > 50 kg

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

- History of significant medical illness

- Positive urine drug screen or alcohol dependance

- Smoking > 10 cigarettes per day

NCT01162889
Pfizer
Terminated
Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People

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Descriptive Information
Brief Title  ICMJE Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
Official Title  ICMJE Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects
Brief SummaryThis is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. One third of the participants will be given an injection or infusion of placebo (sugar water). All participants will be healthy people.
Detailed DescriptionFirst in human single dose study. Study terminated 12 October 2011. The ATR-107 Development team reached a recommendation to terminate further development of ATR-107 (PF-05230900). This was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the First-in-Human study in healthy volunteers (B2281001). This recommendation is not based on adverse events observed in study B2281001.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Placebo SC Injection
    Single injection
  • Drug: ATR-107 (PF-05230900) SC Injection
    Single intravenous infusion, 60 minute duration
  • Drug: ATR-107 (PF-05230900) SC Injection
    Single subcutaneous injection
  • Drug: ATR-107 (PF-05230900) IV Infusion
    Single subcutaneous injection
  • Drug: ATR-107 (PF-05230900) IV Infusion
    Single intravenous infusion, 60 minute duration
  • Drug: Placebo IV Infusion
    Single intravenous infusion, 60 minute duration
Study Arms  ICMJE
  • Placebo Comparator: Placebo - SC injection
    Intervention: Drug: Placebo SC Injection
  • Experimental: Drug dose level 1 - SC injection
    Intervention: Drug: ATR-107 (PF-05230900) SC Injection
  • Experimental: Drug dose level 2 - SC injection
    Intervention: Drug: ATR-107 (PF-05230900) SC Injection
  • Experimental: Drug dose level 3- SC injection
    Intervention: Drug: ATR-107 (PF-05230900) SC Injection
  • Experimental: Drug dose level 4 - SC injection
    Intervention: Drug: ATR-107 (PF-05230900) SC Injection
  • Experimental: Drug dose level 5 - SC injection
    Intervention: Drug: ATR-107 (PF-05230900) SC Injection
  • Experimental: Drug dose level 6 - IV Infusion
    Intervention: Drug: ATR-107 (PF-05230900) IV Infusion
  • Experimental: Drug dose level 7 - IV Infusion
    Intervention: Drug: ATR-107 (PF-05230900) IV Infusion
  • Experimental: Drug dose level 8 - IV infusion
    Intervention: Drug: ATR-107 (PF-05230900) IV Infusion
  • Placebo Comparator: Placebo - IV infusion
    Intervention: Drug: Placebo IV Infusion
  • Experimental: Drug dose level 9 - IV infusion
    Intervention: Drug: ATR-107 (PF-05230900) IV Infusion
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: December 22, 2011)
70
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2010)
72
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion DateJanuary 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females of non-childbearing potential
  • Body mass index between 17.5 to 30.5 and body weight > 50 kg

Exclusion Criteria:

  • History of significant medical illness
  • Positive urine drug screen or alcohol dependance
  • Smoking > 10 cigarettes per day
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 NCT01162889
Other Study ID Numbers  ICMJE B2281001
3243K1-1000
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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