Healthy
Conditions
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.
Interventions
BIOLOGICALPF-06730512
Comparison of different dosages of PF-06730512 to Placebo
DRUGPlacebo
Comparison of Placebo to different doses of PF-06730512
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Exclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Terminal half-life, as permitted | Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) | Terminal half-life, 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 |
| Minimum observed concentration during the dosing interval (Cmin) | Day 1 to approximately Day 113 | Minimum observed concentration during the dosing interval (Cmin) |
| 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) |
| Accumulation ratio (Rac), as permitted | Day 1 to approximately Day 113 | Accumulation ratio (Rac), as permitted |
| 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 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 |
| 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 |
Countries
Belgium
Outcome results
None listed