A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

Detailed Description
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First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects

Official Title
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Ascending Single Dose Study Of The Safety, Tolerability, And Pharmacokinetics Of PF-05230905 Administered Subcutaneously Or Intravenously To Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-05230905


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. Receipt or treatment with an investigational or marketed biologic drug. blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

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

Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PF-05230905<br>9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo | Drug: PF-05230905<br>* Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo. |  | day 168 | 
| Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated. |  | day 168 | 
| Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects. |  | day 168 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of development of Anti Drug Antibody. |  | day 168 | 
| Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters. |  | day 168 | 
| Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined. |  | day 168 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy subject, safety, PK study, healthy volunteers