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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohorts 1-8 Experimental Arm | Experimental |
| |
| SAD Cohorts 1-8 Placebo Arm | Placebo Comparator |
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| MAD Cohorts 9-11 Experimental Arm | Experimental |
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| MAD Cohorts 9-11 Placebo Arm | Placebo Comparator |
| |
| MAD Cohort 12 Experimental Arm | Experimental |
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| MAD Cohort 12 Placebo Arm | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06480605 | Drug | Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting or intolerability treatment related adverse events (AEs). | 6 weeks | |
| Incidence, severity and causal relationship of treatment emergent AEs (TEAEs) and withdrawals due to treatment emergent adverse events. | 6 weeks | |
| Incidence and magnitude of abnormal laboratory findings. | 6 weeks | |
| Abnormal and clinically relevant changes in vital signs, blood pressure (BP) and electrocardiogram (ECG) parameters. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Single Ascending Dose: Maximum Observed Plasma Concentration (Cmax) | 6 weeks | |
| Single Ascending Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) | 6 weeks | |
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Inclusion Criteria:
Healthy male and/or female subjects of non childbearing potential 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 and clinical laboratory tests).
Female subjects of non childbearing potential must meet at least one of the following criteria:
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31758576 | Derived | Banfield C, Rudin D, Bhattacharya I, Goteti K, Li G, Hassan-Zahraee M, Brown LS, Hung KE, Pawlak S, Lepsy C. First-in-human, randomized dose-escalation study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PF-06480605 in healthy subjects. Br J Clin Pharmacol. 2020 Apr;86(4):812-824. doi: 10.1111/bcp.14187. Epub 2020 Jan 28. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo | Drug | Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format. |
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| PF-06480605 | Drug | Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk). |
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| Placebo | Drug | Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk). |
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| PF-06480605 | Drug | Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk). |
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| Placebo | Drug | Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk). |
|
| Single Ascending Dose: Area under the plasma concentration-time profile from time zero to 14 days (AUC14 days) |
| 6 weeks |
| Single Ascending Dose: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) | 6 weeks |
| Single Ascending Dose: Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast) | 6 weeks |
| Single Ascending Dose: Dose normalized maximum plasma concentration (Cmax[dn]) | 6 weeks |
| Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf[dn]) | 6 weeks |
| Single Ascending Dose: Dose normalized area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (AUClast[dn]) | 6 weeks |
| Single Ascending Dose: Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 6 weeks |
| Single Ascending Dose: Mean residence time(MRT) | 6 weeks |
| Single Ascending Dose: Volume of Distribution at Steady State (Vss) | 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 blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 6 weeks |
| Single Ascending Dose: Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 6 weeks |
| Multiple Ascending Dose First Dose: Maximum Observed Plasma Concentration (Cmax) | 6 weeks |
| Multiple Ascending Dose First Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) | 6 weeks |
| Multiple Ascending Dose First Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ) | 6 weeks |
| Multiple Ascending Dose First Dose: Dose normalized maximum plasma concentration (Cmax[dn]) | 6 weeks |
| Multiple Ascending Dose First Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn]) | 6 weeks |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 6 weeks |
| Multiple Ascending Dose First Dose: Mean residence time (MRT) | 6 weeks |
| 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. | 6 weeks |
| Multiple Ascending Dose First Dose: Volume of Distribution at Steady State (Vss) | 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 blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 6 weeks |
| Multiple Ascending Dose First Dose: 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. | 6 weeks |
| Multiple Ascending Dose First Dose: Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Maximum Observed Plasma Concentration (Cmax) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Dose normalized maximum plasma concentration (Cmax[dn]) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Dose normalized Area under the plasma concentration-time profile from time zero to time τ, the dosing interval where τ=2 weeks (AUCτ [dn]) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 6 weeks |
| Multiple Ascending Dose Multiple Dose: 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. | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Volume of Distribution at Steady State (Vss) | 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 blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | 6 weeks |
| Multiple Ascending Dose Multiple Dose: 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. | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Minimum Observed Plasma Trough Concentration (Cmin) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Average concentration at steady state (Cav) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Observed accumulation ratio (Rac) | 6 weeks |
| Multiple Ascending Dose Multiple Dose: Peak to trough fluctuation (PTF) | 6 weeks |
| Multiple Ascending Dose Additional Parameter: estimate of bioavailability (F) for subcutaneous administration at the corresponding intravenous dose | 6 weeks |
| Immunogenicity for both Single Ascending Dose and Multiple Ascending Dose: Development of anti-drug antibodies (ADA) | 6 weeks |