Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

Study Overview
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Brief Summary
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This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.

Official Title
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Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06410293 and Adalimumab Sourced From US And EU Administered To Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: PF-06410293
* Biological: Humira (adalimumab-EU)
* Biological: Humira (adalimumab-US)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing. Exclusion Criteria: Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>PF-06410293 | Biological: PF-06410293<br>* 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.<br>* Other names: adalimumab-Pfizer;|
| Active Comparator: B<br>Adalimumab-EU | Biological: Humira (adalimumab-EU)<br>* 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.<br>* Other names: adalimumab (European Union);|
| Active Comparator: C<br>Adalimumab-US | Biological: Humira (adalimumab-US)<br>* 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.<br>* Other names: adalimumab (United States);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) |  | Day 1 - Day 43 | 
| Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast) |  | Day 1 - Day 43 | 
| Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf) |  | Day 1 - Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab) |  | Day 1 - Day 71 | 
| Time to Reach Maximum Observed Serum Concentration (Tmax) |  | Day 1- Day 43 | 
| Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing |  | Day 1- Day 43 | 
| Systemic Clearance (CL) |  | Day 1- Day 43 | 
| Serum Decay Half-Life (t1/2) | Serum decay half-life is teh time for the serum concentration to decrease by one half | Day 1- Day 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Phase 1, PK, adalimumab, Single-dose, Immunology, Bioequivalence, Biosimilarity, Similarity.