Clinical trial NCT02237729: A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Healthy Subjects (REFLECTIONS B538-07))
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: healthy subjects
immunology
PK
Phase 1
bioequivalence
biosimilarity
adalimumab
single dose.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: maximal serum concentration (Cmax)
timeFrame: Day 1 - Day 50
measure: area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk)
timeFrame: 0-336 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)]
timeFrame: Day 1 - Day 50
measure: AUC extrapolated to infinity (AUC0inf)
timeFrame: Day 1 - Day 50
Secondary outcomes:
measure: Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters
timeFrame: Day 1- Day 71
measure: Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb)
timeFrame: Day 1- Day 71
measure: maximal serum concentration (Cmax) for adalimumab EU as compared to adalimumab US
timeFrame: Day 1 - Day 50
measure: area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) for adalimumab EU as compared to adalimumab US
timeFrame: 0-336 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] for adalimumab EU as compared to adalimumab US
timeFrame: Day 1 - Day 50
measure: AUC extrapolated to infinity (AUC0inf) for adalimumab EU as compared to adalimumab US
timeFrame: Day 1 - Day 50
measure: time to reach the maximum concentration (Tmax)
timeFrame: Day 1 - Day 50
measure: Apparent clearance (CL/F)
timeFrame: Day 1 - Day 50
measure: Apparent volume of distribution (Vz/F)
timeFrame: Day 1 - Day 50
measure: Terminal half-life (T1/2)
timeFrame: Day 1 - Day 50
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: De La Pedraja Radiology Associates
state: Florida
city: Jacksonville
country: United States
facility: SeaView Jacksonville
state: Florida
city: Miami
country: United States
facility: SeaView Research, Inc.
state: Florida
city: Miami
country: United States
facility: SeaView Reseach Screening Office
state: Florida
city: Miami
country: United States
facility: SeaView Research, Inc. (Screening Office)
state: Florida
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
city: Saint Paul
country: United States
facility: Prism Research, LLC
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: