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

Pfizer210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

210

Conditions

Healthy

Interventions

PF-06410293BIOLOGICAL

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Humira (adalimumab-EU)BIOLOGICAL

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Humira (adalimumab-US)BIOLOGICAL

40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

New Haven, Connecticut, United States

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Maximum Observed Serum Concentration (Cmax)

Time frame: Day 1 - Day 43

Area Under the Curve From Time Zero to Last Time Point with Quantifiable Concentration (AUClast)

Time frame: Day 1 - Day 43

Area under the Concentration-Time Curve (AUC) from Time Zero extrapolated to infinity (AUCInf)

Time frame: Day 1 - Day 43

Secondary Outcomes

Incidence of anti-adalimumab antibodies (ADA) and neutralizing antibodies (Nab)

Time frame: Day 1 - Day 71

Time to Reach Maximum Observed Serum Concentration (Tmax)

Time frame: Day 1- Day 43

Area under the Concentration-Time Curve (AUC) time Zero to 2 weeks after Dosing

Time frame: Day 1- Day 43

Systemic Clearance (CL)

Time frame: 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

Time frame: Day 1- Day 43

Data from ClinicalTrials.gov

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