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

NCT ID: NCT01162889

Last Updated: 2012-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo - SC injection

Group Type PLACEBO_COMPARATOR

Placebo SC Injection

Intervention Type DRUG

Single injection

Drug dose level 1 - SC injection

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) SC Injection

Intervention Type DRUG

Single intravenous infusion, 60 minute duration

Drug dose level 2 - SC injection

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) SC Injection

Intervention Type DRUG

Single subcutaneous injection

Drug dose level 3- SC injection

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) SC Injection

Intervention Type DRUG

Single subcutaneous injection

Drug dose level 4 - SC injection

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) SC Injection

Intervention Type DRUG

Single subcutaneous injection

Drug dose level 5 - SC injection

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) SC Injection

Intervention Type DRUG

Single subcutaneous injection

Drug dose level 6 - IV Infusion

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) IV Infusion

Intervention Type DRUG

Single subcutaneous injection

Drug dose level 7 - IV Infusion

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) IV Infusion

Intervention Type DRUG

Single intravenous infusion, 60 minute duration

Drug dose level 8 - IV infusion

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) IV Infusion

Intervention Type DRUG

Single intravenous infusion, 60 minute duration

Placebo - IV infusion

Group Type PLACEBO_COMPARATOR

Placebo IV Infusion

Intervention Type DRUG

Single intravenous infusion, 60 minute duration

Drug dose level 9 - IV infusion

Group Type EXPERIMENTAL

ATR-107 (PF-05230900) IV Infusion

Intervention Type DRUG

Single intravenous infusion, 60 minute duration

Interventions

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Placebo SC Injection

Single injection

Intervention Type DRUG

ATR-107 (PF-05230900) SC Injection

Single intravenous infusion, 60 minute duration

Intervention Type DRUG

ATR-107 (PF-05230900) SC Injection

Single subcutaneous injection

Intervention Type DRUG

ATR-107 (PF-05230900) SC Injection

Single subcutaneous injection

Intervention Type DRUG

ATR-107 (PF-05230900) SC Injection

Single subcutaneous injection

Intervention Type DRUG

ATR-107 (PF-05230900) SC Injection

Single subcutaneous injection

Intervention Type DRUG

ATR-107 (PF-05230900) IV Infusion

Single subcutaneous injection

Intervention Type DRUG

ATR-107 (PF-05230900) IV Infusion

Single intravenous infusion, 60 minute duration

Intervention Type DRUG

ATR-107 (PF-05230900) IV Infusion

Single intravenous infusion, 60 minute duration

Intervention Type DRUG

Placebo IV Infusion

Single intravenous infusion, 60 minute duration

Intervention Type DRUG

ATR-107 (PF-05230900) IV Infusion

Single intravenous infusion, 60 minute duration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2281001&StudyName=Study%20To%20Assess%20The%20Safety%20And%20Tolerability%20Of%20Increasing%20Single%20Doses%20Of%20ATR-107%20%28PF-05230900%29%20In%20Healthy%20People

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

Other Identifiers

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3243K1-1000

Identifier Type: -

Identifier Source: secondary_id

B2281001

Identifier Type: -

Identifier Source: org_study_id

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