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

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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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

62 participants in 2 patient groups, including a placebo group

Placebo injection SC/IV
Placebo Comparator group
Description:
Placebo for injection SC/IV
Treatment:
Drug: Placebo injection SC/IV
PF-06823859
Active Comparator group
Description:
Study Drug being used in the study
Treatment:
Biological: PF-06823859

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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