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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PF-06410293 (Biological); Humira (adalimumab-EU) (Biological); Humira (adalimumab-US) (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Primary outcome:

Maximum Observed Serum Concentration (Cmax)

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

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

Secondary outcome:

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

Time to Reach Maximum Observed Serum Concentration (Tmax)

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

Systemic Clearance (CL)

Serum Decay Half-Life (t1/2)

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 and Contacts

Pfizer Investigational Site, Brussels B-1070, Belgium

Pfizer Investigational Site, New Haven, Connecticut 06511, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2013
Last updated: February 13, 2014

Page last updated: August 23, 2015

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