Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
- Conditions
- Healthy
- Interventions
- Drug: PlaceboBiological: PF-06730512
- Registration Number
- NCT03146065
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- Healthy female subjects of nonchildbearing potential and/or 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 (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (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 lb).
- History of allergic reactions to diagnostic or therapeutic protein. History of recurrent infections or active infection within 28 days of screening.
Exposure to live vaccines within 28 days of screening.
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of subject vaccination is permissible.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for IV/SC administration PF-06730512 PF-06730512 Study Drug being used in the study
- Primary Outcome Measures
Name Time Method Number of subjects with injection site reaction(s) Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose) Number of subjects with injection site reaction(s)
Number of subjects with laboratory test findings of potential clinical importance 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 Treatment Emergent Treatment-Related Adverse Event(s) Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose) Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Number of subjects with vital signs findings of potential clinical importance 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 ECG findings of potential clinical importance Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose) Number of subjects with ECG findings of potential clinical importance
- Secondary Outcome Measures
Name Time Method Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted 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
Apparent Volume of Distribution of PF-06730512, as permitted Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) Apparent Volume of Distribution of PF-06730512, as permitted
Maximum Observed Plasma Concentration (Cmax) of PF-06730512 Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb) Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted 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
Minimum observed concentration during the dosing interval (Cmin) Day 1 to approximately Day 113 Minimum observed concentration during the dosing interval (Cmin)
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512 Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512 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 End of Dosing Interval (AUCtau) of PF-06730512 Day 1 to approximately Day 113 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
Terminal half-life, as permitted Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) Terminal half-life, as permitted
Accumulation ratio (Rac), as permitted Day 1 to approximately Day 113 Accumulation ratio (Rac), as permitted
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit
🇧🇪Brussels, Belgium