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

Study Overview
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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.

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.

Official Title
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Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of ATR-107 Administered Subcutaneously And Intravenously To Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo SC Injection
* Drug: ATR-107 (PF-05230900) SC Injection
* Drug: ATR-107 (PF-05230900) SC Injection
* Drug: ATR-107 (PF-05230900) SC Injection
* Drug: ATR-107 (PF-05230900) SC Injection
* Drug: ATR-107 (PF-05230900) SC Injection
* Drug: ATR-107 (PF-05230900) IV Infusion
* Drug: ATR-107 (PF-05230900) IV Infusion
* Drug: ATR-107 (PF-05230900) IV Infusion
* Drug: Placebo IV Infusion
* Drug: ATR-107 (PF-05230900) IV Infusion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 20 months | 
| Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz |  | 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, Crohn's disease