Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-03-31

Brief Summary

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This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD Cohorts 1-8 Experimental Arm

Group Type EXPERIMENTAL

PF-06480605

Intervention Type DRUG

Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.

SAD Cohorts 1-8 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.

MAD Cohorts 9-11 Experimental Arm

Group Type EXPERIMENTAL

PF-06480605

Intervention Type DRUG

Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).

MAD Cohorts 9-11 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).

MAD Cohort 12 Experimental Arm

Group Type EXPERIMENTAL

PF-06480605

Intervention Type DRUG

Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).

MAD Cohort 12 Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).

Interventions

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PF-06480605

Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.

Intervention Type DRUG

Placebo

Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.

Intervention Type DRUG

PF-06480605

Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).

Intervention Type DRUG

Placebo

Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).

Intervention Type DRUG

PF-06480605

Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).

Intervention Type DRUG

Placebo

Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Female subjects of non childbearing potential must meet at least one of the following criteria:

1. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
* 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 3 months 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, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
* Subjects with a history of autoimmune disorders.
* Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
* History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding the first dose of study medication.
* Pregnant females; breastfeeding females; and females of childbearing potential.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes