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

Healthy

Intervention / Treatment

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)

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

United States
- 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

14 years to 51 years (Adult)

Accepts Healthy Volunteers

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo - SC injection	Drug: Placebo SC Injection Single injection
Experimental: Drug dose level 1 - SC injection	Drug: ATR-107 (PF-05230900) SC Injection Single intravenous infusion, 60 minute duration Drug: ATR-107 (PF-05230900) SC Injection Single subcutaneous injection
Experimental: Drug dose level 2 - SC injection	Drug: ATR-107 (PF-05230900) SC Injection Single intravenous infusion, 60 minute duration Drug: ATR-107 (PF-05230900) SC Injection Single subcutaneous injection
Experimental: Drug dose level 3- SC injection	Drug: ATR-107 (PF-05230900) SC Injection Single intravenous infusion, 60 minute duration Drug: ATR-107 (PF-05230900) SC Injection Single subcutaneous injection
Experimental: Drug dose level 4 - SC injection	Drug: ATR-107 (PF-05230900) SC Injection Single intravenous infusion, 60 minute duration Drug: ATR-107 (PF-05230900) SC Injection Single subcutaneous injection
Experimental: Drug dose level 5 - SC injection	Drug: ATR-107 (PF-05230900) SC Injection Single intravenous infusion, 60 minute duration Drug: ATR-107 (PF-05230900) SC Injection Single subcutaneous injection
Experimental: Drug dose level 6 - IV Infusion	Drug: ATR-107 (PF-05230900) IV Infusion Single subcutaneous injection Drug: ATR-107 (PF-05230900) IV Infusion Single intravenous infusion, 60 minute duration
Experimental: Drug dose level 7 - IV Infusion	Drug: ATR-107 (PF-05230900) IV Infusion Single subcutaneous injection Drug: ATR-107 (PF-05230900) IV Infusion Single intravenous infusion, 60 minute duration
Experimental: Drug dose level 8 - IV infusion	Drug: ATR-107 (PF-05230900) IV Infusion Single subcutaneous injection Drug: ATR-107 (PF-05230900) IV Infusion Single intravenous infusion, 60 minute duration
Placebo Comparator: Placebo - IV infusion	Drug: Placebo IV Infusion Single intravenous infusion, 60 minute duration
Experimental: Drug dose level 9 - IV infusion	Drug: ATR-107 (PF-05230900) IV Infusion Single subcutaneous injection Drug: ATR-107 (PF-05230900) IV Infusion 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

Pfizer

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.

Helpful Links

To obtain contact information for a study center near you, click here.

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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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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on Placebo SC Injection

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