Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: PF-06823859

Drug: Placebo injection SC/IV

Study type

Interventional

Funder types

Industry

Identifiers

NCT02766621

C0251001

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.

Enrollment

62 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female subjects of non childbearing potential and 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, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
Subjects with a history of autoimmune disorders.
Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).