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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Biological: Adalimumab-US; Biological: PF-06410293; Biological: Adalimumab-EU

• Registration Number: NCT02237729
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-10
• Last Update Posted: 2015-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab-US	Adalimumab-US	-
PF-06410293	PF-06410293	-
Adalimumab-EU	Adalimumab-EU	Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Vince & Associates Clinical Research, Inc.; 🇺🇸 Overland Park, Kansas, United States

Prism Research, LLC; 🇺🇸 Saint Paul, Minnesota, United States

De La Pedraja Radiology Associates; 🇺🇸 Coral Gables, Florida, United States

SeaView Research, Inc.; 🇺🇸 Miami, Florida, United States

SeaView Jacksonville; 🇺🇸 Jacksonville, Florida, United States

SeaView Reseach Screening Office; 🇺🇸 Miami, Florida, United States

SeaView Research, Inc. (Screening Office); 🇺🇸 Miami, Florida, United States