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

• ClinicalTrials.gov Identifier: NCT02237729
• Recruitment Status: Completed
• First Posted: September 11, 2014
• Last Update Posted: April 13, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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

Condition or disease	Intervention/treatment	Phase
Healthy Subjects	Biological: PF-06410293; Biological: Adalimumab-US; Biological: Adalimumab-EU	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 362 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• 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 Start Date: September 2014
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: PF-06410293	Biological: PF-06410293; PF-06410293 will be administered as a single 40 mg, subcutaneous dose; Other Name: Adalimumab-Pfizer
Active Comparator: Adalimumab-US	Biological: Adalimumab-US; Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
Active Comparator: Adalimumab-EU; Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose	Biological: Adalimumab-EU; Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose

Outcome Measures

Primary Outcome Measures :

1. maximal serum concentration (Cmax) [ Time Frame: Day 1 - Day 50 ]
   maximal serum concentration (Cmax)
2. area under the concentration time curve (AUC) from time 0 to 2 weeks (AUC0-2wk) [ Time Frame: 0-336 hours ]
   area under the concentration time curve (AUC) from time 0 to 336 hours (AUC0-2wk)
3. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-T)] [ Time Frame: 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)
4. AUC extrapolated to infinity (AUC0inf) [ Time Frame: Day 1 - Day 50 ]
   AUC extrapolated to infinity (AUC0inf)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

De La Pedraja Radiology Associates

Coral Gables, Florida, United States, 33134

SeaView Jacksonville

Jacksonville, Florida, United States, 32256

SeaView Research, Inc.

Miami, Florida, United States, 33126

SeaView Reseach Screening Office

Miami, Florida, United States, 33134

SeaView Research, Inc. (Screening Office)

Miami, Florida, United States, 33134

United States, Kansas

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, United States, 66211

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, United States, 66212

United States, Minnesota

Prism Research, LLC

Saint Paul, Minnesota, United States, 55114

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02237729
• Other Study ID Numbers: B5381007; REFLECTIONS B538-07
• First Posted: September 11, 2014
• Last Update Posted: April 13, 2015
• Last Verified: April 2015

Keywords provided by Pfizer:

healthy subjects; immunology; PK; Phase 1; bioequivalence; biosimilarity; adalimumab; single dose.

Additional relevant MeSH terms:

Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents