Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/1/2017 |
| Start Date: | May 2016 |
| End Date: | August 2017 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
Phase 1, Randomized, Double-Blind, Third-Party Open Placebo-Controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of PF-06823859 In Healthy Subjects
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.
escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections
of PF 06823859 in healthy subjects.
Inclusion Criteria:
1. 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.
2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lbs).
Exclusion Criteria:
1. History of active or latent tuberculosis (TB) regardless of treatment; positive
Quantiferon - TB test.
2. Subjects with a history of autoimmune disorders.
3. 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).
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