- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162889
Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
March 13, 2012 updated by: Pfizer
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.
Study Overview
Status
Terminated
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
-
-
Kansas
-
Overland Park, Kansas, United States, 66211
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo - SC injection
|
Single injection
|
Experimental: Drug dose level 1 - SC injection
|
Single intravenous infusion, 60 minute duration
Single subcutaneous injection
|
Experimental: Drug dose level 2 - SC injection
|
Single intravenous infusion, 60 minute duration
Single subcutaneous injection
|
Experimental: Drug dose level 3- SC injection
|
Single intravenous infusion, 60 minute duration
Single subcutaneous injection
|
Experimental: Drug dose level 4 - SC injection
|
Single intravenous infusion, 60 minute duration
Single subcutaneous injection
|
Experimental: Drug dose level 5 - SC injection
|
Single intravenous infusion, 60 minute duration
Single subcutaneous injection
|
Experimental: Drug dose level 6 - IV Infusion
|
Single subcutaneous injection
Single intravenous infusion, 60 minute duration
|
Experimental: Drug dose level 7 - IV Infusion
|
Single subcutaneous injection
Single intravenous infusion, 60 minute duration
|
Experimental: Drug dose level 8 - IV infusion
|
Single subcutaneous injection
Single intravenous infusion, 60 minute duration
|
Placebo Comparator: Placebo - IV infusion
|
Single intravenous infusion, 60 minute duration
|
Experimental: Drug dose level 9 - IV infusion
|
Single subcutaneous injection
Single intravenous infusion, 60 minute duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment-emergent AEs and SAEs, AEs leading to withdrawal, immunogenicity, injection and infusion reactions, and clinically significant changes in laboratory tests, vital signs and ECGs if reported.
Time Frame: 20 months
|
20 months
|
Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz
Time Frame: 19 months
|
19 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
June 9, 2010
First Submitted That Met QC Criteria
July 13, 2010
First Posted (Estimate)
July 15, 2010
Study Record Updates
Last Update Posted (Estimate)
March 15, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2281001
- 3243K1-1000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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