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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Device: PF-06410293 PFS; Device: PF-06410293 PFP

• Registration Number: NCT02572245
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Study Start: 2016-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. 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.
2. Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 pounds).
3. 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.
4. 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.

Exclusion Criteria

1. 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).
2. Evidence or history of nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain Barré syndrome).
3. History of relevant orthostatic hypotension, fainting spells or blackouts.
4. 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
PF-06410293 PFS (Prefilled Syringe)	PF-06410293 PFS	PF-06410293 40 mg administered by Prefilled Syringe (PFS)
PF-06410293 PFP (Prefilled Pen)	PF-06410293 PFP	PF-06410293 40 mg administered by Prefilled pen

Primary Outcome Measures

Name	Time	Method
Area under the concentration curve (AUC 0-2wk)	Day 1-Day 15
Maximum serum concentration (Cmax)	Day 1 - Day 15

Secondary Outcome Measures

Name	Time	Method
Time to reach the maximum serum concentration (Tmax)	Day 1 - Day 43
AUC extrapolated to infinity (AUC0 inf)	Day 1 - Day 43
Apparent clearance (CL/F)	Day 1 - Day 43
Terminal half life (t1/2)	Day 1 - Day 43
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	Mean injection site pain over a 24 hour period post dose rated by subject on a visual analog scale (VAS), compared for injection by PFS or PFP, and for the 2 injection locations using each device
AUC from time 0 to the last time point with quantifiable concentration (AUCT)	Day 1 - Day 43
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	Mean injection site tolerability using the Modified Draize Scale Numerical Grade over 24 hours post dose rated by the blinded Safety Assessor, compared for injection by PFS or PFP, and for the 2 injection locations using each device
Volume of distribution (Vz/F),	Day 1 - Day 43

Trial Locations

Locations (1)

ICON Early Phase Services, LLC; 🇺🇸 San Antonio, Texas, United States