A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects

NCT02572245 | Completed Phase 1

• 1 other identifier: B5381005
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC) injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects

Conditions

Healthy Subjects

Keywords

Healthy Subjects; Device; PK; Phase 1; Bioequivalence; Adalimumab; Single Dose

Outcome Measures

Primary Outcomes (2)

• Maximum serum concentration (Cmax)

  Day 1 - Day 15

• Area under the concentration curve (AUC 0-2wk)

  Day 1-Day 15

Secondary Outcomes (8)

• Injection site tolerability (Subject Assessment - Visual Analog Scale) - Mean Injection site pain over 24 hour period post dose

  Hour 0 (immediately after injection), 15 minutes, 1, 3, 8, 12 and 24 hours post injection

• Injection site tolerability (Blinded Safety Assessor - Modified Draize Scale) - Mean injection site tolerability over 24 hour post dose

  1, 3, 8, 12 and 24 hours post injection

• Time to reach the maximum serum concentration (Tmax)

  Day 1 - Day 43

• AUC from time 0 to the last time point with quantifiable concentration (AUCT)

  Day 1 - Day 43

• AUC extrapolated to infinity (AUC0 inf)

  Day 1 - Day 43

Study Arms (2)

PF-06410293 PFS (Prefilled Syringe)

ACTIVE COMPARATOR

PF-06410293 40 mg administered by Prefilled Syringe (PFS)

Device: PF-06410293 PFS

PF-06410293 PFP (Prefilled Pen)

ACTIVE COMPARATOR

PF-06410293 40 mg administered by Prefilled pen

Device: PF-06410293 PFP

Interventions

PF-06410293 PFS DEVICE

PF-06410293 40 mg administered subcutaneously by Prefilled syringe

PF-06410293 PFS (Prefilled Syringe)

PF-06410293 PFP DEVICE

PF-06410293 40 mg administered subcutaneously by prefilled pen

PF-06410293 PFP (Prefilled Pen)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects and/or male subjects, who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and pulse rate measurement, 12 lead electrocardiogram (ECG), and clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 pounds).
• Chest X ray with no evidence of current, active TB or previous (inactive) TB, fungal or 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.
• Female subjects of non childbearing potential must meet at least one of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post menopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure.
• All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.

You may not qualify if:

• Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Previous history of cancer, except for adequately treated basal cell or squamous cell carcinoma of the skin

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

Related Publications (1)

• Cox DS, Alvarez DF, Bock AE, Cronenberger CL. Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1166-1173. doi: 10.1002/cpdd.939. Epub 2021 Mar 25.

  PMID: 33765358 DERIVED

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: October 8, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

US (1)