The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
80
Placebo
Single SC Dose
Single SC Dose
Pfizer Investigational Site
New Haven, Connecticut, United States
Incidence of dose limiting or intolerable treatment related AEs
Time frame: 60 days
Incidence of treatment emergent AEs
Time frame: 60 days
Incidence of abnormal laboratory findings
Time frame: 60 days
Changes from baseline in safety laboratory assessments
Time frame: 60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
Time frame: 60 days
Incidence of anti-drug-antibodies
Time frame: 60 days
Severity of treatment emergent AEs
Time frame: 60 days
Causal relationship of treatment emergent AEs
Time frame: 60 days
Area under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Time frame: 60 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 60 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 60 days
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Single SC Dose
Single SC Dose
Single SC Dose
Single IV Dose
Single SC Dose
Single IV Dose
Single SC Dose
Single IV Dose
PK parameter estimates including T1/2.
Time frame: 60 days
Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 60 days
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 60 days
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 60 days