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-06730512 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
79
Comparison of different dosages of PF-06730512 to Placebo
Comparison of Placebo to different doses of PF-06730512
Pfizer Clinical Research Unit
Brussels, Belgium
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with injection site reaction(s)
Number of subjects with injection site reaction(s)
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with laboratory test findings of potential clinical importance
Number of subjects with laboratory test findings of potential clinical importance
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with vital signs findings of potential clinical importance
Number of subjects with vital signs findings of potential clinical importance
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with ECG findings of potential clinical importance
Number of subjects with ECG findings of potential clinical importance
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
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Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] of PF-06730512, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted
Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
Time frame: Day 1 to approximately Day 113
Apparent Volume of Distribution of PF-06730512, as permitted
Apparent Volume of Distribution of PF-06730512, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Terminal half-life, as permitted
Terminal half-life, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Accumulation ratio (Rac), as permitted
Accumulation ratio (Rac), as permitted
Time frame: Day 1 to approximately Day 113
Minimum observed concentration during the dosing interval (Cmin)
Minimum observed concentration during the dosing interval (Cmin)
Time frame: Day 1 to approximately Day 113
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)