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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 May 9, 2018

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
18-55 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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Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects
This 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.
First 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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
January 2012
January 2012   (Final data collection date for primary outcome measure)

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
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
 
 
NCT01162889
B2281001
3243K1-1000
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

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

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