A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects

Official Title
-----------------
A Phase 1, Open-label, Randomized, Single Dose, Parallel Group Comparability Study To Assess The Pharmacokinetics Of Pf-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: PF-06410293 PFS
* Device: PF-06410293 PFP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds). Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist. Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential. Exclusion Criteria: Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome). History of relevant orthostatic hypotension, fainting spells or blackouts. Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF-06410293 PFS (Prefilled Syringe)<br>PF-06410293 40 mg administered by Prefilled Syringe (PFS) | Device: PF-06410293 PFS<br>* PF-06410293 40 mg administered subcutaneously by Prefilled syringe<br>|
| Active Comparator: PF-06410293 PFP (Prefilled Pen)<br>PF-06410293 40 mg administered by Prefilled pen | Device: PF-06410293 PFP<br>* PF-06410293 40 mg administered subcutaneously by prefilled pen<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax) |  | Day 1 - Day 15 | 
| Area under the concentration curve (AUC 0-2wk) |  | Day 1-Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose | Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device | Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection | 
| Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose | Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device | 1, 3, 8, 12 and 24 hours post injection | 
| Time to reach the maximum serum concentration (Tmax) |  | Day 1 - Day 43 | 
| AUC from time 0 to the last time point with quantifiable concentration (AUCT) |  | Day 1 - Day 43 | 
| AUC extrapolated to infinity (AUC0 inf) |  | Day 1 - Day 43 | 
| Volume of distribution (Vz/F), |  | Day 1 - Day 43 | 
| Apparent clearance (CL/F) |  | Day 1 - Day 43 | 
| Terminal half life (t1/2) |  | Day 1 - Day 43 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects, Device, PK, Phase 1, Bioequivalence, Adalimumab, Single Dose