A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))

Study Overview
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Brief Summary
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This is a Phase 1, double blind (sponsor open), randomized (1:1:1), parallel group, 3 arm, single dose comparative PK study of adalimumab Pfizer and adalimumab sourced from the US and EU administered subcutaneously (SC) to healthy male and female volunteers

Official Title
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Phase 1, Double Blind, Randomized, Parallel-group, 3-arm, Single-dose, Comparative Pharmacokinetic Study Of Pf-06410293 and Adalimumab Sourced From Us And Eu Administered To Healthy Male And Female Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Biological: PF-06410293
* Biological: Adalimumab-US
* Biological: Adalimumab-EU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects between the ages of 18 and 45 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests. Body Mass Index (BMI) of 19.0 to 30.5 kg/m2; and a total body weight >60 kg (132 lbs). Chest X ray with no evidence of current, active TB or previous (inactive) TB, 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. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06410293<br> | Biological: PF-06410293<br>* PF-06410293 will be administered as a single 40 mg, subcutaneous dose<br>* Other names: Adalimumab-Pfizer;|
| Active Comparator: Adalimumab-US<br> | Biological: Adalimumab-US<br>* Adalimumab-US will be administered as a single 40 mg, subcutaneous dose<br>|
| Active Comparator: Adalimumab-EU<br>Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose | Biological: Adalimumab-EU<br>* Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal serum concentration (Cmax) | maximal serum concentration (Cmax) | Day 1 - Day 50 | 
| area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) | area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) | 0-336 hours | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] | AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) | Day 1 - Day 50 | 
| AUC extrapolated to infinity (AUC0inf) | AUC extrapolated to infinity (AUC0inf) | Day 1 - Day 50 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters | Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters | Day 1- Day 71 | 
| Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) | Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) | Day 1- Day 71 | 
| maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US | maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 | 
| area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US | area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk) for adalimumab EU as compared to adalimumab US | 0-336 hours | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US | AUC (0-T)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-T) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 | 
| AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US | AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US | Day 1 - Day 50 | 
| time to reach the maximum concentration (Tmax) | time to reach the maximum concentration (Tmax) | Day 1 - Day 50 | 
| Apparent clearance (CL/F) | Apparent clearance (CL/F) | Day 1 - Day 50 | 
| Apparent volume of distribution (Vz/F) | Apparent volume of distribution (Vz/F) | Day 1 - Day 50 | 
| Terminal half-life (T1/2) | Terminal half-life (T1/2) | Day 1 - Day 50 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PK, healthy subjects, immunology, Phase 1, bioequivalence, biosimilarity, adalimumab, single dose.