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

Telavant

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-06480605

Study type: Interventional

Funder types: Industry

Identifiers

NCT01989143

B7541001

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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92 participants in 6 patient groups, including a placebo group

SAD Cohorts 1-8 Experimental Arm

Experimental group

Treatment:

Drug: PF-06480605

Drug: PF-06480605

Drug: PF-06480605

SAD Cohorts 1-8 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

MAD Cohorts 9-11 Experimental Arm

Experimental group

Treatment:

Drug: PF-06480605

Drug: PF-06480605

Drug: PF-06480605

MAD Cohorts 9-11 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

MAD Cohort 12 Experimental Arm

Experimental group

Treatment:

Drug: PF-06480605

Drug: PF-06480605

Drug: PF-06480605

MAD Cohort 12 Placebo Arm

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo