Neoplasms
Conditions
Keywords
Immunotherapy, PF-04518600, PF-05082566, solid tumors, tumors, neoplasm metastasis, Phase 1, hepatocellular carcinoma, HCC, liver cancer, ocular melanoma, melanoma, clear cell renal cell carcinoma, RCC, kidney cancer, head and neck squamous cell carcinoma, HNSCC, head and neck cancer, cervical cancer, cancer of the cervix, gastric cancer, stomach cancer, non small cell lung cancer, NSCLC, lung cancer, urothelial bladder carcinoma, bladder cancer, OX40, 4-1BB
Brief summary
To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Interventions
DRUGPF-04518600
Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined
DRUGPF-04518600 plus PF-05082566
Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy. * Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed. * Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy. * Part B2 Arm 1 only: 1. Ocular melanoma patients with advanced/metastatic disease, or 2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. \[Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.\] Any questions on prior treatment may be discussed with the Sponsor. Arm 2 only: * Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. \[Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.\] * Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function
Exclusion criteria
* Brain metastases requiring steroids * Major surgery, Radiation therapy within 4 weeks of starting study treatment (except: palliative radiotherapy to a limited field is allowed after consultation with sponsor's medical monitor at any time during study participation, including during screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas) * Active and clinically significant bacterial, fungal, or viral infection * History of active autoimmune disorders * History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy * Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2) * Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | The first 2 cycles of treatment (Day 1 up to Day 28) | DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported. |
| Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period. | Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With Laboratory Test Abnormalities in Part A | The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \[protein, blood\], microscopy \[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\], miscellaneous \[urine casts and bacteria\]). |
| Number of Participants With DLTs in Part B1 | The First 2 Cycles of Treatment (Day 1 up to Day 28) | DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported. |
| Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period. | Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Number of Participants With Laboratory Test Abnormalities in Part B | The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable) | Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \[protein, blood\], microscopy \[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\], miscellaneous \[urine casts and bacteria\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rates at Months 6, 12, and 24 in Part A | Baseline up to 24 months post first dose. | Probability of survival at 6, 12, and 24 months after the first dose of study treatment. |
| Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1. |
| Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks. |
| Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf). |
| Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration. |
| Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data. |
| Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cav was defined as average serum concentration over the dosing interval. |
| Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau |
| Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Vss was defined as volume of distribution at steady state. |
| Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1. |
| Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | Baseline up to end of treatment (maximum of 14 weeks). | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. |
| Mean Unbound Cell Surface OX40 in Part A1 | Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1 | Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses. |
| ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | Baseline up to 24 months post first dose. | ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set. CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \<10 mm. PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. |
| Kaplan-Meier Estimate of Median PFS in Part B | Baseline up to 24 months post first dose. | PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause. PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST. |
| Kaplan-Meier Estimate of Median TTP in Part B | Baseline up to 24 months post first dose. | TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST. |
| Number of Participants Having SD in Part B | Baseline up to 24 months post first dose. | SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits. |
| Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1. |
| Kaplan-Meier Estimate of Median DoR in Part B | Baseline up to 24 months post first dose. | DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm) and all target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed. |
| Kaplan-Meier Estimate of Median OS in Part B | Baseline up to 24 months post first dose. | OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months. |
| Overall Survival Rates at Months 6, 12, and 24 in Part B | Baseline up to 24 months post first dose. | Probability of survival at 6, 12, and 24 months after the first dose of study treatment. |
| Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1. |
| AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks. |
| AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf). |
| t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration. |
| Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data. |
| Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cav was defined as average serum concentration over the dosing interval. |
| CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau |
| Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Vss was defined as volume of distribution at steady state. |
| Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1. |
| Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1. |
| AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks. |
| AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf). |
| t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration. |
| Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data. |
| Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Cav was defined as average serum concentration over the dosing interval. |
| CL of Utomilumab Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau |
| Vss of Utomilumab Following Multiple Doses on C3D1 in Part B | For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3. | Vss was defined as volume of distribution at steady state. |
| Number of Participants With ADA and NAb Against PF-04518600 in Part B | Baseline up to end of treatment (maximum of 14 weeks). | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. |
| Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | Baseline up to 24 months post first dose. | ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set. CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \<10 mm. PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%. |
| Number of Participants With ADA and NAb Against Utomilumab in Part B | Baseline up to end of treatment (maximum of 14 weeks). | ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point. |
| Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | Baseline up to 24 months post first dose | PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause. PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST. |
| Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | Baseline up to 24 months post first dose | TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST. |
| Number of Participants Having Stable Disease (SD) in Part A | Baseline up to 24 months post first dose. | SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits. |
| Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | Baseline up to 24 months post first dose. | DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm) and all target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed. |
| Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | Baseline up to 24 months post first dose. | OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44. |
Countries
France, Japan, Netherlands, United States
Participant flow
Recruitment details
Part A (PF-04518600 monotherapy) included Part A1 and Part A2 Part B(PF-04518600 plus utomilumab \[PF-05082566\] combination therapy) included Part B1 and Part B2
Pre-assignment details
A total of 174 participants were enrolled in this study, and 174 of them received study treatment. For Part A, 87 participants were enrolled and treated with PF-04518600 at several dose levels. For Part B, 87 participants were enrolled and treated with PF-04518600+utomilumab at several dose levels.
Participants by arm
| Arm | Count |
|---|---|
| Part A1: PF-04518600 0.01mg/kg Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 2 |
| Part A1: PF-04518600 0.1mg/kg Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 10 |
| Part A1: PF-04518600 0.3mg/kg Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 11 |
| Part A1: PF-04518600 1.5mg/kg Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 12 |
| Part A1: PF-04518600 3.0mg/kg Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 13 |
| Part A1: PF-04518600 10mg/kg Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 4 |
| Part A2: PF-04518600 30mg Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 16 |
| Part A2: PF-04518600 250mg Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks. | 19 |
| Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws. | 11 |
| Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws. | 12 |
| Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws. | 12 |
| Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws. | 11 |
| Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws. | 11 |
| Part B2: PF-04518600 30mg + PF-05082566 20mg Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws. | 30 |
| Total | 174 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 2 | 7 | 6 | 11 | 10 | 3 | 9 | 9 | 10 | 8 | 10 | 7 | 8 | 21 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 1 | 0 | 2 | 1 | 0 | 0 | 1 | 2 | 0 | 4 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Study ongoing at date of cut-off | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Subject refused further follow-up | 0 | 2 | 2 | 0 | 0 | 0 | 2 | 3 | 0 | 1 | 1 | 2 | 2 | 4 |
Baseline characteristics
| Characteristic | Part A1: PF-04518600 0.01mg/kg | Total | Part B2: PF-04518600 30mg + PF-05082566 20mg | Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg | Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg | Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg | Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg | Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg | Part A2: PF-04518600 250mg | Part A2: PF-04518600 30mg | Part A1: PF-04518600 10mg/kg | Part A1: PF-04518600 3.0mg/kg | Part A1: PF-04518600 1.5mg/kg | Part A1: PF-04518600 0.3mg/kg | Part A1: PF-04518600 0.1mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18 to 44 years old (18-44) | 0 participants | 11 participants | 3 participants | 0 participants | 0 participants | 1 participants | 0 participants | 2 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 2 participants | 1 participants |
| Age, Customized 45 to 64 years old (45-64) | 2 participants | 85 participants | 14 participants | 3 participants | 4 participants | 8 participants | 7 participants | 7 participants | 9 participants | 8 participants | 1 participants | 7 participants | 2 participants | 6 participants | 7 participants |
| Age, Customized 65 years old and more than 65 years old (>＝65) | 0 participants | 78 participants | 13 participants | 8 participants | 7 participants | 3 participants | 5 participants | 2 participants | 9 participants | 8 participants | 2 participants | 6 participants | 10 participants | 3 participants | 2 participants |
| Age, Customized Less than 18 years old | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Body mass index | 27.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 6.7 | 25.2 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.9 | 25.2 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.3 | 23.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.9 | 25.0 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.2 | 25.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 7.4 | 26.7 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 7.6 | 25.3 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.2 | 25.5 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 6 | 26.2 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 3.7 | 22.8 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 1.9 | 25.9 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 4.5 | 28.9 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 5.7 | 26.4 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 4.9 | 26.6 kilograms per meter squared (kg/m^2) STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 16 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 143 Participants | 24 Participants | 11 Participants | 11 Participants | 11 Participants | 8 Participants | 9 Participants | 14 Participants | 8 Participants | 3 Participants | 13 Participants | 11 Participants | 11 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 15 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized ASIAN | 0 participants | 30 participants | 4 participants | 3 participants | 3 participants | 2 participants | 2 participants | 1 participants | 5 participants | 2 participants | 0 participants | 4 participants | 3 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized BLACK | 1 participants | 6 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 3 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized OTHER | 0 participants | 10 participants | 3 participants | 0 participants | 0 participants | 0 participants | 4 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized UNSPECIFIED | 0 participants | 11 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 7 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized WHITE | 1 participants | 117 participants | 20 participants | 8 participants | 8 participants | 10 participants | 6 participants | 10 participants | 8 participants | 6 participants | 4 participants | 8 participants | 9 participants | 9 participants | 10 participants |
| Sex: Female, Male Female | 1 Participants | 49 Participants | 10 Participants | 9 Participants | 3 Participants | 7 Participants | 4 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 125 Participants | 20 Participants | 2 Participants | 8 Participants | 5 Participants | 8 Participants | 7 Participants | 16 Participants | 16 Participants | 4 Participants | 11 Participants | 11 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 7 / 10 | 6 / 11 | 11 / 12 | 10 / 13 | 3 / 4 | 9 / 16 | 9 / 19 | 10 / 11 | 8 / 12 | 10 / 12 | 7 / 11 | 8 / 11 | 22 / 30 |
| other Total, other adverse events | 2 / 2 | 10 / 10 | 11 / 11 | 12 / 12 | 13 / 13 | 4 / 4 | 16 / 16 | 19 / 19 | 11 / 11 | 12 / 12 | 12 / 12 | 11 / 11 | 11 / 11 | 29 / 30 |
| serious Total, serious adverse events | 0 / 2 | 4 / 10 | 1 / 11 | 3 / 12 | 6 / 13 | 2 / 4 | 7 / 16 | 6 / 19 | 5 / 11 | 2 / 12 | 3 / 12 | 5 / 11 | 5 / 11 | 10 / 30 |
Outcome results
Primary
Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B
Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality TEAEs | 11 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related TEAEs | 4 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality SAEs | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related TEAEs | 6 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality TEAEs | 12 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality SAEs | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality SAEs | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related TEAEs | 7 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality TEAEs | 12 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality TEAEs | 11 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality SAEs | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related TEAEs | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related SAEs | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality SAEs | 5 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related TEAEs | 7 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality TEAEs | 11 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related TEAEs | 22 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality SAEs | 10 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B | Number of Participants with all-causality TEAEs | 30 Participants |
Primary
Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A
Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.
Population: Analysis population included all enrolled participants who received at least one full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 4 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 7 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 10 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 11 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 7 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 12 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 7 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 6 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 7 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 13 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 4 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 7 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 16 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 11 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related TEAEs | 12 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with treatment-related SAEs | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality SAEs | 6 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A | Number of Participants with all-causality TEAEs | 19 Participants |
Primary
Number of Participants With DLTs in Part B1
DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.
Time frame: The First 2 Cycles of Treatment (Day 1 up to Day 28)
Population: The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With DLTs in Part B1 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With DLTs in Part B1 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With DLTs in Part B1 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With DLTs in Part B1 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With DLTs in Part B1 | 0 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1
DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.
Time frame: The first 2 cycles of treatment (Day 1 up to Day 28)
Population: The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1 | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities in Part A
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \[protein, blood\], microscopy \[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\], miscellaneous \[urine casts and bacteria\]).
Time frame: The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)
Population: Analysis Population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 4 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 7 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 6 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 5 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatine Kinase (CK) (U/L) > 2.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 7 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatine Kinase (CK) (U/L) > 2.0 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 6 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 7 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 10 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 8 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 5 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 9 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 6 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 5 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 8 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatine Kinase (CK) (U/L) > 2.0 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 4 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 9 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 10 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 3 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 10 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 6 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 9 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 3 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Neutrophils (%) <0.8x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Neutrophils (%) >1.2x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 3 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 5 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 4 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 5 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 4 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 5 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 5 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 3 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 6 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 5 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 4 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | PT International Ratio (INR) > 1.1 x ULN | 6 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Neutrophils (%) >1.2x ULN | 3 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Epithelial Cells (/HPF) >= 6 | 3 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Neutrophils (%) <0.8x LLN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 5 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Hematocrit (%) < 0.8 x LLN | 5 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Bilirubin (mg/dL) > 1.5 x ULN | 5 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 3 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Magnesium (mg/dL) > 1.1 x ULN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lipase (U/L) > 1.5 x ULN | 3 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) < 0.8 x LLN | 3 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatine Kinase (CK) (U/L) > 2.0 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Direct Bilirubin (mg/dL) > 1.5 x ULN | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) < 0.8 x LLN | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (%) < 0.8 x LLN | 10 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Sodium (milliequivalent (mEq/L) < 0.95 x LLN | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Creatinine (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Gamma GT (IU/L) > 3.0 x ULN | 10 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Phosphate (mg/dL) > 1.2 x ULN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 9 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Blood/ hemoglobin(Hgb) (Qual) >= 1 | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN | 8 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Hyaline Casts (/LPF) >1 | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine RBC (/high power field (HPF)) >= 20 | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Casts (/low power field(LPF) > 1 | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | T4 (free) (ng/dL) > 1.2 x ULN | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Uric Acid (mg/dL) > 1.2 x ULN | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 5 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine WBC (/HPF) >= 20 | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Protein (Qual) >= 1 | 5 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Monocytes (%) > 1.2 x ULN | 12 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) < 0.8 x LLN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Amylase (U/L) > 1.5 x ULN | 5 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (%) > 1.2 x ULN | 6 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 7 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (%) > 1.2 x ULN | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | TSH (UIU/mL) > 1.2 x ULN | 6 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Prothrombin (PT) (sec) > 1.1 x ULN | 6 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Platelets (10**3/mm**3) < 0.5 x LLN | 2 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Calcium (mg/dL) > 1.1 x ULN | 1 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | PTT (sec) > 1.1 x ULN | 4 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Laboratory Test Abnormalities in Part A | Glucose (mg/dL) > 1.5 x ULN | 5 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities in Part B
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \[protein, blood\], microscopy \[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\], miscellaneous \[urine casts and bacteria\]).
Time frame: The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PTT (sec) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Prothrombin (PT) (sec) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PT International Ratio (INR) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Epithelial Cells (/HPF) >= 6 | 5 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Gamma GT (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine WBC (/HPF) >= 20 | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine RBC (/HPF) >= 20 | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Blood/Hgb (Qual) >= 1 | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Protein (Qual) >= 1 | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lipase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Amylase (U/L) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN | 5 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) < 0.8 x LLN | 8 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 3 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 4 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) < 0.95 x LLN | 0 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Uric Acid (mg/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hematocrit (%) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatinine (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PTT (sec) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hematocrit (%) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) < 0.8 x LLN | 8 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatinine (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Prothrombin (PT) (sec) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PT International Ratio (INR) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Gamma GT (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine WBC (/HPF) >= 20 | 4 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Uric Acid (mg/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) < 0.5 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine RBC (/HPF) >= 20 | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Blood/Hgb (Qual) >= 1 | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Hyaline Casts (/LPF) >1 | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Protein (Qual) >= 1 | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) < 0.95 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lipase (U/L) > 1.5 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Amylase (U/L) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) > 1.5 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Granular Casts (/LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Epithelial Cells (/HPF) >= 6 | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Direct Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Direct Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hematocrit (%) < 0.8 x LLN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN | 8 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) < 0.8 x LLN | 9 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 5 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 6 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (%) > 1.2 x ULN | 6 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 5 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PTT (sec) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Prothrombin (PT) (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PT International Ratio (INR) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Gamma GT (IU/L) > 3.0 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatinine (mg/dL) > 1.3 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Uric Acid (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) < 0.95 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) < 0.9 x LLN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) < 0.9 x LLN | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) > 1.5 x ULN | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Amylase (U/L) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lipase (U/L) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Protein (Qual) >= 1 | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Blood/Hgb (Qual) >= 1 | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine RBC (/HPF) >= 20 | 1 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine WBC (/HPF) >= 20 | 4 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Epithelial Cells (/HPF) >= 6 | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Hyaline Casts (/LPF) >1 | 2 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 7 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) < 0.9 x LLN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Gamma GT (IU/L) > 3.0 x ULN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN | 6 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Direct Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Epithelial Cells (/HPF) >= 6 | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) < 0.8 x LLN | 9 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hematocrit (%) < 0.8 x LLN | 6 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine RBC (/HPF) >= 20 | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Uric Acid (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatinine (mg/dL) > 1.3 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Blood/Hgb (Qual) >= 1 | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine WBC (/HPF) >= 20 | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) < 0.9 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 6 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Protein (Qual) >= 1 | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Hyaline Casts (/LPF) >1 | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) < 0.8 x LLN | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Prothrombin (PT) (sec) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) < 0.95 x LLN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lipase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 7 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (%) > 1.2 x ULN | 6 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Amylase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatine Kinase (CK) (U/L) > 2.0 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) > 1.5 x ULN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PT International Ratio (INR) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PTT (sec) > 1.1 x ULN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatinine (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 5 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Uric Acid (mg/dL) > 1.2 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) < 0.95 x LLN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (%) > 1.2 x ULN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PT International Ratio (INR) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Epithelial Cells (/HPF) >= 6 | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 6 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) > 1.1 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 5 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) < 0.8 x LLN | 9 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN | 6 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) < 0.8 x LLN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Granular Casts (/LPF) > 1 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Bilirubin (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) > 1.5 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Amylase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lipase (U/L) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Protein (Qual) >= 1 | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Hyaline Casts (/LPF) >1 | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Blood/Hgb (Qual) >= 1 | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine RBC (/HPF) >= 20 | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Gamma GT (IU/L) > 3.0 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Direct Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hematocrit (%) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Prothrombin (PT) (sec) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) < 0.8 x LLN | 3 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PTT (sec) > 1.1 x ULN | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine WBC (/HPF) >= 20 | 2 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Gamma GT (IU/L) > 3.0 x ULN | 5 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Neutrophils (%) <0.8x LLN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Uric Acid (mg/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Amylase (U/L) > 1.5 x ULN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Prothrombin (PT) (sec) > 1.1 x ULN | 11 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Neutrophils (%) >1.2x ULN | 6 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 9 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) < 0.95 x LLN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lipase (U/L) > 1.5 x ULN | 7 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN) | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine WBC (/HPF) >= 20 | 7 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (Abs) (10**3/mm**3) > 1.2 x ULN | 5 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Chloride (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alkaline Phosphatase (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Protein (Qual) >= 1 | 7 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Epithelial Cells (/HPF) >= 6 | 6 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Platelets (10**3/mm**3) < 0.5 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) > 1.1 x ULN | 5 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN) | 9 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Blood/Hgb (Qual) >= 1 | 7 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PT International Ratio (INR) > 1.1 x ULN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Basophils (%) > 1.2 x ULN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Hyaline Casts (/LPF) >1 | 5 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Potassium (mEq/L) < 0.9 x LLN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (%) > 1.2 x ULN | 14 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatinine (mg/dL) > 1.3 x ULN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN | 12 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Indirect Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine RBC (/HPF) >= 20 | 4 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | T4 (free) (ng/dL) > 1.2 x ULN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN | 10 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Sodium (mEq/L) > 1.05 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) < 0.8 x LLN | 20 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Phosphate (mg/dL) < 0.8 x LLN | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Albumin (g/dL) < 0.8 x LLN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Casts (/LPF) > 1 | 2 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) > 1.5 x ULN | 6 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | PTT (sec) > 1.1 x ULN | 7 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | TSH (UIU/mL) > 1.2 x ULN | 5 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Direct Bilirubin (mg/dL) > 1.5 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Granular Casts (/LPF) > 1 | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Magnesium (mg/dL) < 0.9 x LLN | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Hematocrit (%) < 0.8 x LLN | 4 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) < 0.6 x LLN | 1 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Calcium (mg/dL) > 1.1 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Lymphocytes (%) > 1.2 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Blood Urea Nitrogen (BUN) (mg/dL) > 1.3 x ULN | 5 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Urine Bacteria (/HPF) > 20 | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Monocytes (%) > 1.2 x ULN | 9 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Glucose (mg/dL) > 1.5 x ULN | 10 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN | 15 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | Creatine Kinase (CK) (U/L) > 2.0 x ULN | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Laboratory Test Abnormalities in Part B | White Blood Cell Count (10**3/mm**3) < 0.6 x LLN | 0 Participants |
Secondary
Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 0.9893 ratio | Geometric Coefficient of Variation 110 |
| Part A1: PF-04518600 0.3mg/kg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 1.543 ratio | Geometric Coefficient of Variation 32 |
| Part A1: PF-04518600 1.5mg/kg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 1.785 ratio | Geometric Coefficient of Variation 12 |
| Part A1: PF-04518600 3.0mg/kg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 1.947 ratio | Geometric Coefficient of Variation 12 |
| Part A1: PF-04518600 10mg/kg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 2.161 ratio | Geometric Coefficient of Variation 13 |
| Part A2: PF-04518600 30mg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 1.628 ratio | Geometric Coefficient of Variation 19 |
| Part A2: PF-04518600 250mg | Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A | 1.709 ratio | Geometric Coefficient of Variation 21 |
Secondary
Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.
Vss was defined as volume of distribution at steady state.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 39.17 milliliter/kilograms (mL/kg) | Geometric Coefficient of Variation 19 |
| Part A1: PF-04518600 3.0mg/kg | Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 55.3 milliliter/kilograms (mL/kg) | — |
| Part A2: PF-04518600 30mg | Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 79.2 milliliter/kilograms (mL/kg) | — |
| Part A2: PF-04518600 250mg | Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 94.3 milliliter/kilograms (mL/kg) | — |
Secondary
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 380.7 μg*hr/mL | Geometric Coefficient of Variation 56 |
| Part A1: PF-04518600 0.1mg/kg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 293.7 μg*hr/mL | Geometric Coefficient of Variation 34 |
| Part A1: PF-04518600 0.3mg/kg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | NA μg*hr/mL | — |
| Part A1: PF-04518600 3.0mg/kg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 33800 μg*hr/mL | — |
| Part A1: PF-04518600 3.0mg/kg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 23000 μg*hr/mL | — |
| Part A2: PF-04518600 30mg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | NA μg*hr/mL | — |
| Part A2: PF-04518600 30mg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 1180 μg*hr/mL | — |
| Part A2: PF-04518600 250mg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 35000 μg*hr/mL | — |
| Part A2: PF-04518600 250mg | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 22700 μg*hr/mL | — |
Secondary
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 7.59 microgram•hour/milliliter (µg•hr/mL) | — |
| Part A1: PF-04518600 0.1mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 303.5 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 35 |
| Part A1: PF-04518600 0.1mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 299 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 151 |
| Part A1: PF-04518600 0.3mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 2072 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 36 |
| Part A1: PF-04518600 0.3mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 1350 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 20 |
| Part A1: PF-04518600 1.5mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 6218 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 23 |
| Part A1: PF-04518600 1.5mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 11610 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 3.0mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 25600 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 21 |
| Part A1: PF-04518600 3.0mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 12810 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 17 |
| Part A1: PF-04518600 10mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 38220 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 19 |
| Part A1: PF-04518600 10mg/kg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 82710 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 32 |
| Part A2: PF-04518600 30mg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 1375 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 25 |
| Part A2: PF-04518600 30mg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 2236 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 37 |
| Part A2: PF-04518600 250mg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 25380 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 29 |
| Part A2: PF-04518600 250mg | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 14360 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 19 |
Secondary
AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 283.5 μg*hr/mL | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 0.01mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA μg*hr/mL | — |
| Part A1: PF-04518600 0.1mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | NA μg*hr/mL | — |
| Part A1: PF-04518600 0.3mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | NA μg*hr/mL | — |
| Part A1: PF-04518600 1.5mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2710 μg*hr/mL | — |
| Part A1: PF-04518600 3.0mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 9480 μg*hr/mL | — |
| Part A1: PF-04518600 10mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 1130 μg*hr/mL | — |
| Part A1: PF-04518600 10mg/kg | AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 1657 μg*hr/mL | Geometric Coefficient of Variation 22 |
Secondary
AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 467 μg*hr/mL | — |
| Part A1: PF-04518600 0.01mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 1011 μg*hr/mL | Geometric Coefficient of Variation 20 |
| Part A1: PF-04518600 0.1mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 831 μg*hr/mL | — |
| Part A1: PF-04518600 0.3mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 2801 μg*hr/mL | Geometric Coefficient of Variation 25 |
| Part A1: PF-04518600 1.5mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 1950 μg*hr/mL | — |
| Part A1: PF-04518600 1.5mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 2252 μg*hr/mL | Geometric Coefficient of Variation 34 |
| Part A1: PF-04518600 3.0mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 3137 μg*hr/mL | Geometric Coefficient of Variation 15 |
| Part A1: PF-04518600 3.0mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA μg*hr/mL | — |
| Part A1: PF-04518600 10mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA μg*hr/mL | — |
| Part A1: PF-04518600 10mg/kg | AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 626.4 μg*hr/mL | Geometric Coefficient of Variation 47 |
Secondary
AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 340.2 µg.hr/mL | Geometric Coefficient of Variation 73 |
| Part A1: PF-04518600 0.01mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 270.7 µg.hr/mL | Geometric Coefficient of Variation 27 |
| Part A1: PF-04518600 0.1mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 1739 µg.hr/mL | Geometric Coefficient of Variation 26 |
| Part A1: PF-04518600 0.1mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 1022 µg.hr/mL | Geometric Coefficient of Variation 29 |
| Part A1: PF-04518600 0.3mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2239 µg.hr/mL | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 0.3mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 1177 µg.hr/mL | Geometric Coefficient of Variation 23 |
| Part A1: PF-04518600 1.5mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 4034 µg.hr/mL | Geometric Coefficient of Variation 35 |
| Part A1: PF-04518600 1.5mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 3089 µg.hr/mL | Geometric Coefficient of Variation 19 |
| Part A1: PF-04518600 3.0mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 10100 µg.hr/mL | Geometric Coefficient of Variation 19 |
| Part A1: PF-04518600 3.0mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 19190 µg.hr/mL | Geometric Coefficient of Variation 48 |
| Part A1: PF-04518600 10mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2291 µg.hr/mL | Geometric Coefficient of Variation 45 |
| Part A1: PF-04518600 10mg/kg | AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 1624 µg.hr/mL | Geometric Coefficient of Variation 30 |
Secondary
AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 789.4 µg•hr/mL | Geometric Coefficient of Variation 23 |
| Part A1: PF-04518600 0.01mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA µg•hr/mL | — |
| Part A1: PF-04518600 0.1mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 596 µg•hr/mL | Geometric Coefficient of Variation 43 |
| Part A1: PF-04518600 0.1mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 343.7 µg•hr/mL | Geometric Coefficient of Variation 225 |
| Part A1: PF-04518600 0.3mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 2465 µg•hr/mL | Geometric Coefficient of Variation 33 |
| Part A1: PF-04518600 0.3mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2765 µg•hr/mL | Geometric Coefficient of Variation 77 |
| Part A1: PF-04518600 1.5mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 2289 µg•hr/mL | Geometric Coefficient of Variation 25 |
| Part A1: PF-04518600 1.5mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 673.9 µg•hr/mL | Geometric Coefficient of Variation 1191 |
| Part A1: PF-04518600 3.0mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 2839 µg•hr/mL | Geometric Coefficient of Variation 15 |
| Part A1: PF-04518600 3.0mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2621 µg•hr/mL | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 10mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 561.8 µg•hr/mL | Geometric Coefficient of Variation 53 |
| Part A1: PF-04518600 10mg/kg | AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 232.1 µg•hr/mL | Geometric Coefficient of Variation 1524 |
Secondary
Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A
Cav was defined as average serum concentration over the dosing interval.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.8897 µg/mL | Geometric Coefficient of Variation 151 |
| Part A1: PF-04518600 0.3mg/kg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 6.166 µg/mL | Geometric Coefficient of Variation 36 |
| Part A1: PF-04518600 1.5mg/kg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 34.55 µg/mL | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 3.0mg/kg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 76.13 µg/mL | Geometric Coefficient of Variation 20 |
| Part A1: PF-04518600 10mg/kg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 246.1 µg/mL | Geometric Coefficient of Variation 32 |
| Part A2: PF-04518600 30mg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 6.659 µg/mL | Geometric Coefficient of Variation 37 |
| Part A2: PF-04518600 250mg | Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 75.55 µg/mL | Geometric Coefficient of Variation 29 |
Secondary
Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B
Cav was defined as average serum concentration over the dosing interval.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.013 µg/mL | Geometric Coefficient of Variation 73 |
| Part A1: PF-04518600 0.1mg/kg | Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | 5.175 µg/mL | Geometric Coefficient of Variation 26 |
| Part A1: PF-04518600 0.3mg/kg | Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | 6.664 µg/mL | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 1.5mg/kg | Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | 12 µg/mL | Geometric Coefficient of Variation 35 |
| Part A1: PF-04518600 3.0mg/kg | Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | 57.15 µg/mL | Geometric Coefficient of Variation 48 |
| Part A1: PF-04518600 10mg/kg | Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B | 6.815 µg/mL | Geometric Coefficient of Variation 45 |
Secondary
Cav of Utomilumab Following Multiple Doses on C3D1 in Part B
Cav was defined as average serum concentration over the dosing interval.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | NA µg/mL | — |
| Part A1: PF-04518600 0.1mg/kg | Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.5119 µg/mL | Geometric Coefficient of Variation 225 |
| Part A1: PF-04518600 0.3mg/kg | Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | 4.119 µg/mL | Geometric Coefficient of Variation 77 |
| Part A1: PF-04518600 1.5mg/kg | Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | 1.004 µg/mL | Geometric Coefficient of Variation 1189 |
| Part A1: PF-04518600 3.0mg/kg | Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | 3.903 µg/mL | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 10mg/kg | Cav of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.3453 µg/mL | Geometric Coefficient of Variation 1524 |
Secondary
Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.3342 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 151 |
| Part A1: PF-04518600 0.3mg/kg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.1448 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 48 |
| Part A1: PF-04518600 1.5mg/kg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.1291 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 3.0mg/kg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.1171 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 21 |
| Part A1: PF-04518600 10mg/kg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.1209 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 32 |
| Part A2: PF-04518600 30mg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.1739 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 28 |
| Part A2: PF-04518600 250mg | Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A | 0.1423 milliliter/hour/kilogram (mL/hr/kg) | Geometric Coefficient of Variation 31 |
Secondary
CL of PF-04518600 Following Multiple Doses on C3D1 in Part B
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.2944 mL/hr/kg | Geometric Coefficient of Variation 73 |
| Part A1: PF-04518600 0.1mg/kg | CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.1725 mL/hr/kg | Geometric Coefficient of Variation 26 |
| Part A1: PF-04518600 0.3mg/kg | CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.1339 mL/hr/kg | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 1.5mg/kg | CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.2481 mL/hr/kg | Geometric Coefficient of Variation 35 |
| Part A1: PF-04518600 3.0mg/kg | CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.1566 mL/hr/kg | Geometric Coefficient of Variation 48 |
| Part A1: PF-04518600 10mg/kg | CL of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.1861 mL/hr/kg | Geometric Coefficient of Variation 47 |
Secondary
CL of Utomilumab Following Multiple Doses on C3D1 in Part B
Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | CL of Utomilumab Following Multiple Doses on C3D1 in Part B | NA mL/hr/kg | — |
| Part A1: PF-04518600 0.1mg/kg | CL of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.05817 mL/hr/kg | Geometric Coefficient of Variation 225 |
| Part A1: PF-04518600 0.3mg/kg | CL of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.03615 mL/hr/kg | Geometric Coefficient of Variation 77 |
| Part A1: PF-04518600 1.5mg/kg | CL of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.1483 mL/hr/kg | Geometric Coefficient of Variation 1187 |
| Part A1: PF-04518600 3.0mg/kg | CL of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.03813 mL/hr/kg | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 10mg/kg | CL of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.08619 mL/hr/kg | Geometric Coefficient of Variation 1525 |
Secondary
Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B
Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 2.290 µg/mL | Geometric Coefficient of Variation 19 |
| Part A1: PF-04518600 0.01mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2.779 µg/mL | Geometric Coefficient of Variation 29 |
| Part A1: PF-04518600 0.1mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 6.965 µg/mL | Geometric Coefficient of Variation 23 |
| Part A1: PF-04518600 0.1mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 9.049 µg/mL | Geometric Coefficient of Variation 21 |
| Part A1: PF-04518600 0.3mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 7.644 µg/mL | Geometric Coefficient of Variation 23 |
| Part A1: PF-04518600 0.3mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 9.359 µg/mL | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 1.5mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 19.63 µg/mL | Geometric Coefficient of Variation 26 |
| Part A1: PF-04518600 1.5mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 19.76 µg/mL | Geometric Coefficient of Variation 45 |
| Part A1: PF-04518600 3.0mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 62.45 µg/mL | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 3.0mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 81.49 µg/mL | Geometric Coefficient of Variation 51 |
| Part A1: PF-04518600 10mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 10.20 µg/mL | Geometric Coefficient of Variation 24 |
| Part A1: PF-04518600 10mg/kg | Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 10.53 µg/mL | Geometric Coefficient of Variation 39 |
Secondary
Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B
Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 4.018 µg/mL | Geometric Coefficient of Variation 33 |
| Part A1: PF-04518600 0.01mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2.909 µg/mL | Geometric Coefficient of Variation 47 |
| Part A1: PF-04518600 0.1mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 4.06 µg/mL | Geometric Coefficient of Variation 39 |
| Part A1: PF-04518600 0.1mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2.554 µg/mL | Geometric Coefficient of Variation 79 |
| Part A1: PF-04518600 0.3mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 20.33 µg/mL | Geometric Coefficient of Variation 43 |
| Part A1: PF-04518600 0.3mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 20.02 µg/mL | Geometric Coefficient of Variation 22 |
| Part A1: PF-04518600 1.5mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 17.63 µg/mL | Geometric Coefficient of Variation 33 |
| Part A1: PF-04518600 1.5mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 17.94 µg/mL | Geometric Coefficient of Variation 39 |
| Part A1: PF-04518600 3.0mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 19.02 µg/mL | Geometric Coefficient of Variation 29 |
| Part A1: PF-04518600 3.0mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 17.84 µg/mL | Geometric Coefficient of Variation 54 |
| Part A1: PF-04518600 10mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 3.232 µg/mL | Geometric Coefficient of Variation 22 |
| Part A1: PF-04518600 10mg/kg | Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2.726 µg/mL | Geometric Coefficient of Variation 47 |
Secondary
Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | 0.2591 µg/mL | Geometric Coefficient of Variation 148 |
| Part A1: PF-04518600 0.1mg/kg | Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | 2.266 µg/mL | Geometric Coefficient of Variation 39 |
| Part A1: PF-04518600 0.3mg/kg | Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.074 µg/mL | Geometric Coefficient of Variation 21520 |
| Part A1: PF-04518600 1.5mg/kg | Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | 5.327 µg/mL | Geometric Coefficient of Variation 101 |
| Part A1: PF-04518600 3.0mg/kg | Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | 30.59 µg/mL | Geometric Coefficient of Variation 38 |
| Part A1: PF-04518600 10mg/kg | Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B | 2.671 µg/mL | Geometric Coefficient of Variation 155 |
Secondary
Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.03294 µg/mL | Geometric Coefficient of Variation 1302300 |
| Part A1: PF-04518600 0.1mg/kg | Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.002776 µg/mL | Geometric Coefficient of Variation 3859511 |
| Part A1: PF-04518600 0.3mg/kg | Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.08612 µg/mL | Geometric Coefficient of Variation 1346874 |
| Part A1: PF-04518600 1.5mg/kg | Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.0413 µg/mL | Geometric Coefficient of Variation 2825205 |
| Part A1: PF-04518600 3.0mg/kg | Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.3123 µg/mL | Geometric Coefficient of Variation 56629 |
| Part A1: PF-04518600 10mg/kg | Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.0007531 µg/mL | Geometric Coefficient of Variation 117304 |
Secondary
Kaplan-Meier Estimate of Median DoR in Part B
DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm) and all target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median DoR in Part B | NA months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median DoR in Part B | NA months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median DoR in Part B | 2.8 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median DoR in Part B | NA months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median DoR in Part B | NA months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median DoR in Part B | NA months |
Secondary
Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A
DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm) and all target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | NA months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | 2.4 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | 21.4 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | NA months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | NA months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | NA months |
| Part A2: PF-04518600 30mg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | NA months |
| Part A2: PF-04518600 250mg | Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A | NA months |
Secondary
Kaplan-Meier Estimate of Median OS in Part B
OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median OS in Part B | 8.7 months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median OS in Part B | 9.5 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median OS in Part B | 12.0 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median OS in Part B | 11.4 months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median OS in Part B | 5.4 months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median OS in Part B | 12.0 months |
Secondary
Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A
OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 11 months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 13.0 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 17.6 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 9.0 months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 7.4 months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 7.5 months |
| Part A2: PF-04518600 30mg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 15.6 months |
| Part A2: PF-04518600 250mg | Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A | 23.9 months |
Secondary
Kaplan-Meier Estimate of Median PFS in Part B
PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause. PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median PFS in Part B | 1.4 months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median PFS in Part B | 2.8 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median PFS in Part B | 2.3 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median PFS in Part B | 1.4 months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median PFS in Part B | 1.4 months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median PFS in Part B | 3.2 months |
Secondary
Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A
PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause. PD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.
Time frame: Baseline up to 24 months post first dose
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 1.3 months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 3.5 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 5.4 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 1.4 months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 2.7 months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 4.8 months |
| Part A2: PF-04518600 30mg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 3.0 months |
| Part A2: PF-04518600 250mg | Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A | 2.8 months |
Secondary
Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A
TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.
Time frame: Baseline up to 24 months post first dose
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 1.3 months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 4.1 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 5.4 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 1.4 months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 3.2 months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 8.3 months |
| Part A2: PF-04518600 30mg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 3.2 months |
| Part A2: PF-04518600 250mg | Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A | 2.8 months |
Secondary
Kaplan-Meier Estimate of Median TTP in Part B
TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Kaplan-Meier Estimate of Median TTP in Part B | 1.4 months |
| Part A1: PF-04518600 0.1mg/kg | Kaplan-Meier Estimate of Median TTP in Part B | 2.8 months |
| Part A1: PF-04518600 0.3mg/kg | Kaplan-Meier Estimate of Median TTP in Part B | 2.6 months |
| Part A1: PF-04518600 1.5mg/kg | Kaplan-Meier Estimate of Median TTP in Part B | 1.4 months |
| Part A1: PF-04518600 3.0mg/kg | Kaplan-Meier Estimate of Median TTP in Part B | 1.4 months |
| Part A1: PF-04518600 10mg/kg | Kaplan-Meier Estimate of Median TTP in Part B | 3.3 months |
Secondary
Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.
Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 0.05952 ug/mL | Geometric Coefficient of Variation 51749 |
| Part A1: PF-04518600 0.3mg/kg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 2.882 ug/mL | Geometric Coefficient of Variation 61 |
| Part A1: PF-04518600 1.5mg/kg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 17.79 ug/mL | Geometric Coefficient of Variation 32 |
| Part A1: PF-04518600 3.0mg/kg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 36.14 ug/mL | Geometric Coefficient of Variation 48 |
| Part A1: PF-04518600 10mg/kg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 130 ug/mL | Geometric Coefficient of Variation 41 |
| Part A2: PF-04518600 30mg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 2.968 ug/mL | Geometric Coefficient of Variation 55 |
| Part A2: PF-04518600 250mg | Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A. | 37.62 ug/mL | Geometric Coefficient of Variation 47 |
Secondary
Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A
Cmax was defined as maximum observed serum concentration and can be observed directly from data. Css,max was the Cmax on C3D1.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The pharmacokinetic (PK) parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 0.231 microgram/milliliter (µg/mL) | — |
| Part A1: PF-04518600 0.1mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 2.871 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 24 |
| Part A1: PF-04518600 0.1mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 2.731 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 54 |
| Part A1: PF-04518600 0.3mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 11.03 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 23 |
| Part A1: PF-04518600 0.3mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 8.448 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 17 |
| Part A1: PF-04518600 1.5mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 36.71 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 21 |
| Part A1: PF-04518600 1.5mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 56.15 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 19 |
| Part A1: PF-04518600 3.0mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 114.9 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 22 |
| Part A1: PF-04518600 3.0mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 75.91 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 18 |
| Part A1: PF-04518600 10mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 268.1 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 20 |
| Part A1: PF-04518600 10mg/kg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 401.1 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 26 |
| Part A2: PF-04518600 30mg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 8.264 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 25 |
| Part A2: PF-04518600 30mg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 10.27 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 32 |
| Part A2: PF-04518600 250mg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE3/DAY1 | 105.7 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 23 |
| Part A2: PF-04518600 250mg | Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A | CYCLE1/DAY1 | 72.05 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 22 |
Secondary
Mean Unbound Cell Surface OX40 in Part A1
Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses.
Time frame: Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1
Population: Analysis Population included all enrolled participants with at least 1 of the OX40 evaluated at pre and/or post dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8 | 26.85 percentage of baseline concentration | Standard Deviation 0.212 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H)) | 33.60 percentage of baseline concentration | Standard Deviation 34.083 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 1.40 percentage of baseline concentration | Standard Deviation 0.283 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 57.00 percentage of baseline concentration | Standard Deviation 19.658 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 35.30 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 56.20 percentage of baseline concentration | Standard Deviation 18.526 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 8.70 percentage of baseline concentration | Standard Deviation 5.798 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 58.45 percentage of baseline concentration | Standard Deviation 18.173 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 8.70 percentage of baseline concentration | Standard Deviation 7.495 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 56.40 percentage of baseline concentration | Standard Deviation 15.274 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 4.50 percentage of baseline concentration | Standard Deviation 1.131 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 56.50 percentage of baseline concentration | Standard Deviation 18.526 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 7.30 percentage of baseline concentration | Standard Deviation 5.94 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 60.85 percentage of baseline concentration | Standard Deviation 15.344 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 1.90 percentage of baseline concentration | Standard Deviation 0.849 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 44.00 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) End of treatment | 53.20 percentage of baseline concentration | Standard Deviation 1.838 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 10.35 percentage of baseline concentration | Standard Deviation 6.859 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 7.55 percentage of baseline concentration | Standard Deviation 4.879 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) End of treatment | 62.50 percentage of baseline concentration | Standard Deviation 20.789 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 1.05 percentage of baseline concentration | Standard Deviation 0.495 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 66.95 percentage of baseline concentration | Standard Deviation 22.698 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8 | 34.30 percentage of baseline concentration | Standard Deviation 3.536 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 46.55 percentage of baseline concentration | Standard Deviation 41.366 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 31.50 percentage of baseline concentration | Standard Deviation 9.051 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 44.35 percentage of baseline concentration | Standard Deviation 36.275 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 61.40 percentage of baseline concentration | Standard Deviation 21.072 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 35.60 percentage of baseline concentration | Standard Deviation 31.961 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8 | 30.95 percentage of baseline concentration | Standard Deviation 3.465 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 51.55 percentage of baseline concentration | Standard Deviation 0.495 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 54.70 percentage of baseline concentration | Standard Deviation 20.648 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 35.70 percentage of baseline concentration | Standard Deviation 5.94 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 60.20 percentage of baseline concentration | Standard Deviation 24.183 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 54.65 percentage of baseline concentration | Standard Deviation 15.203 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 45.95 percentage of baseline concentration | Standard Deviation 41.083 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8 | 27.15 percentage of baseline concentration | Standard Deviation 4.172 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 28.85 percentage of baseline concentration | Standard Deviation 0.778 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 21.10 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 53.90 percentage of baseline concentration | Standard Deviation 21.355 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 34.10 percentage of baseline concentration | Standard Deviation 0.283 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 2.20 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) End of treatment | 58.05 percentage of baseline concentration | Standard Deviation 9.263 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) End of treatment | 1.70 percentage of baseline concentration | Standard Deviation 0.141 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8 | 27.55 percentage of baseline concentration | Standard Deviation 3.606 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 8.20 percentage of baseline concentration | Standard Deviation 0.566 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 3.40 percentage of baseline concentration | Standard Deviation 4.384 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 3.90 percentage of baseline concentration | Standard Deviation 1.273 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 32.30 percentage of baseline concentration | Standard Deviation 11.738 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 3.00 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 3.20 percentage of baseline concentration | Standard Deviation 1.273 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 2.70 percentage of baseline concentration | Standard Deviation 0.99 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 2.75 percentage of baseline concentration | Standard Deviation 3.465 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 0.65 percentage of baseline concentration | Standard Deviation 0.636 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 4.50 percentage of baseline concentration | Standard Deviation 0.566 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 2.50 percentage of baseline concentration | Standard Deviation 1.697 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 5.40 percentage of baseline concentration | Standard Deviation 5.091 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) End of treatment | 2.05 percentage of baseline concentration | Standard Deviation 1.202 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 2.65 percentage of baseline concentration | Standard Deviation 0.778 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 3.00 percentage of baseline concentration | Standard Deviation 1.838 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.90 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 46.35 percentage of baseline concentration | Standard Deviation 11.95 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 2.75 percentage of baseline concentration | Standard Deviation 1.909 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 28.85 percentage of baseline concentration | Standard Deviation 2.758 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 3.25 percentage of baseline concentration | Standard Deviation 2.616 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8 | 30.40 percentage of baseline concentration | Standard Deviation 0.566 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 31.30 percentage of baseline concentration | Standard Deviation 1.98 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 34.40 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 2.60 percentage of baseline concentration | Standard Deviation 1.273 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) End of treatment | 38.50 percentage of baseline concentration | Standard Deviation 3.96 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) End of treatment | 35.30 percentage of baseline concentration | Standard Deviation 2.404 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 49.25 percentage of baseline concentration | Standard Deviation 21.708 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 2.60 percentage of baseline concentration | Standard Deviation 0.99 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 3.20 percentage of baseline concentration | Standard Deviation 2.404 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) End of treatment | 6.10 percentage of baseline concentration | Standard Deviation 6.647 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 49.90 percentage of baseline concentration | Standard Deviation 3.536 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 56.45 percentage of baseline concentration | Standard Deviation 6.01 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 3.80 percentage of baseline concentration | Standard Deviation 1.697 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 52.85 percentage of baseline concentration | Standard Deviation 11.384 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 3.35 percentage of baseline concentration | Standard Deviation 2.051 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 49.75 percentage of baseline concentration | Standard Deviation 18.88 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 49.90 percentage of baseline concentration | Standard Deviation 9.758 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 35.15 percentage of baseline concentration | Standard Deviation 35.426 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) End of treatment | 6.85 percentage of baseline concentration | Standard Deviation 3.182 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 50.85 percentage of baseline concentration | Standard Deviation 8.132 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 49.75 percentage of baseline concentration | Standard Deviation 13.223 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 2.55 percentage of baseline concentration | Standard Deviation 0.778 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 1.85 percentage of baseline concentration | Standard Deviation 2.192 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 54.95 percentage of baseline concentration | Standard Deviation 8.839 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 37.20 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 5.90 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 19.00 percentage of baseline concentration | — |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 6.05 percentage of baseline concentration | Standard Deviation 1.626 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) End of treatment | 52.75 percentage of baseline concentration | Standard Deviation 13.789 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 59.60 percentage of baseline concentration | Standard Deviation 16.546 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 6.05 percentage of baseline concentration | Standard Deviation 4.738 |
| Part A1: PF-04518600 0.01mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 60.65 percentage of baseline concentration | Standard Deviation 17.607 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) End of treatment | 4.77 percentage of baseline concentration | Standard Deviation 7.218 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 19.42 percentage of baseline concentration | Standard Deviation 10.402 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 42.29 percentage of baseline concentration | Standard Deviation 13.59 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 38.83 percentage of baseline concentration | Standard Deviation 8.658 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 32.47 percentage of baseline concentration | Standard Deviation 23.479 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 52.74 percentage of baseline concentration | Standard Deviation 14.199 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8 | 39.53 percentage of baseline concentration | Standard Deviation 7.635 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 24.00 percentage of baseline concentration | Standard Deviation 18.939 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 40.18 percentage of baseline concentration | Standard Deviation 12.164 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 3.66 percentage of baseline concentration | Standard Deviation 3.062 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 40.98 percentage of baseline concentration | Standard Deviation 10.428 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 24.52 percentage of baseline concentration | Standard Deviation 22.304 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 53.80 percentage of baseline concentration | Standard Deviation 9.098 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 46.47 percentage of baseline concentration | Standard Deviation 14.885 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 32.88 percentage of baseline concentration | Standard Deviation 16.059 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 6.21 percentage of baseline concentration | Standard Deviation 6.127 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) End of treatment | 3.93 percentage of baseline concentration | Standard Deviation 4.957 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 41.80 percentage of baseline concentration | Standard Deviation 3.149 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) End of treatment | 47.80 percentage of baseline concentration | Standard Deviation 21.14 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) End of treatment | 13.77 percentage of baseline concentration | Standard Deviation 10.845 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8 | 40.33 percentage of baseline concentration | Standard Deviation 15.04 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 51.54 percentage of baseline concentration | Standard Deviation 15.67 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 9.77 percentage of baseline concentration | Standard Deviation 11.267 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 6.18 percentage of baseline concentration | Standard Deviation 4.811 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 41.43 percentage of baseline concentration | Standard Deviation 14.75 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.04 percentage of baseline concentration | Standard Deviation 0.73 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 4.66 percentage of baseline concentration | Standard Deviation 5.283 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 0.59 percentage of baseline concentration | Standard Deviation 1.415 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 56.10 percentage of baseline concentration | Standard Deviation 15.093 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 11.55 percentage of baseline concentration | Standard Deviation 8.232 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 3.01 percentage of baseline concentration | Standard Deviation 4.378 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 15.21 percentage of baseline concentration | Standard Deviation 11.219 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 4.48 percentage of baseline concentration | Standard Deviation 4.388 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 49.08 percentage of baseline concentration | Standard Deviation 20.277 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 3.91 percentage of baseline concentration | Standard Deviation 2.967 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 5.14 percentage of baseline concentration | Standard Deviation 4.446 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 2.50 percentage of baseline concentration | Standard Deviation 2.571 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 17.42 percentage of baseline concentration | Standard Deviation 18.026 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 3.08 percentage of baseline concentration | Standard Deviation 2.994 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 16.35 percentage of baseline concentration | Standard Deviation 10.85 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 6.81 percentage of baseline concentration | Standard Deviation 7.484 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 3.90 percentage of baseline concentration | Standard Deviation 3.524 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 2.01 percentage of baseline concentration | Standard Deviation 2.507 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) End of treatment | 46.70 percentage of baseline concentration | Standard Deviation 12.775 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 5.35 percentage of baseline concentration | Standard Deviation 4.214 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 50.04 percentage of baseline concentration | Standard Deviation 13.227 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 5.06 percentage of baseline concentration | Standard Deviation 5.735 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 2.90 percentage of baseline concentration | Standard Deviation 2.725 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 6.55 percentage of baseline concentration | Standard Deviation 5.978 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 10.00 percentage of baseline concentration | Standard Deviation 6.387 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 39.14 percentage of baseline concentration | Standard Deviation 12.053 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 4.70 percentage of baseline concentration | Standard Deviation 4.031 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 22.54 percentage of baseline concentration | Standard Deviation 20.118 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8 | 34.08 percentage of baseline concentration | Standard Deviation 8.806 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 45.20 percentage of baseline concentration | Standard Deviation 16.005 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 3.54 percentage of baseline concentration | Standard Deviation 2.463 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 36.50 percentage of baseline concentration | Standard Deviation 6.84 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) End of treatment | 37.88 percentage of baseline concentration | Standard Deviation 15.626 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.50 percentage of baseline concentration | Standard Deviation 0.306 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8 | 36.30 percentage of baseline concentration | Standard Deviation 10.886 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 59.39 percentage of baseline concentration | Standard Deviation 15.181 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 38.64 percentage of baseline concentration | Standard Deviation 5.538 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 12.13 percentage of baseline concentration | Standard Deviation 11.505 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 50.57 percentage of baseline concentration | Standard Deviation 12.243 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 49.54 percentage of baseline concentration | Standard Deviation 12.391 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 9.56 percentage of baseline concentration | Standard Deviation 10.163 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 5.19 percentage of baseline concentration | Standard Deviation 3.873 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 24.3 percentage of baseline concentration | Standard Deviation 15.719 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 9.53 percentage of baseline concentration | Standard Deviation 7.607 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 11.54 percentage of baseline concentration | Standard Deviation 10.077 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 62.78 percentage of baseline concentration | Standard Deviation 19.629 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) End of treatment | 34.00 percentage of baseline concentration | Standard Deviation 16.913 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 56.11 percentage of baseline concentration | Standard Deviation 14.652 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H)) | 2.10 percentage of baseline concentration | Standard Deviation 2.621 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 10.33 percentage of baseline concentration | Standard Deviation 9.138 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 47.52 percentage of baseline concentration | Standard Deviation 15.688 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 1.10 percentage of baseline concentration | Standard Deviation 0.868 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.06 percentage of baseline concentration | Standard Deviation 0.36 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 51.48 percentage of baseline concentration | Standard Deviation 21.069 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 4.28 percentage of baseline concentration | Standard Deviation 4.129 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 11.34 percentage of baseline concentration | Standard Deviation 11.046 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 49.92 percentage of baseline concentration | Standard Deviation 11.834 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) End of treatment | 9.80 percentage of baseline concentration | Standard Deviation 11.895 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 12.00 percentage of baseline concentration | Standard Deviation 10.795 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 55.98 percentage of baseline concentration | Standard Deviation 10.071 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) End of treatment | 31.13 percentage of baseline concentration | Standard Deviation 22.871 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 0.36 percentage of baseline concentration | Standard Deviation 0.519 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 27.44 percentage of baseline concentration | Standard Deviation 24.644 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) End of treatment | 63.00 percentage of baseline concentration | Standard Deviation 21.165 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 12.11 percentage of baseline concentration | Standard Deviation 7.99 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8 | 38.83 percentage of baseline concentration | Standard Deviation 8.536 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 50.61 percentage of baseline concentration | Standard Deviation 16.877 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 57.26 percentage of baseline concentration | Standard Deviation 18.236 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 35.28 percentage of baseline concentration | Standard Deviation 14.278 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 3.41 percentage of baseline concentration | Standard Deviation 2.948 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 58.76 percentage of baseline concentration | Standard Deviation 16.535 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 42.69 percentage of baseline concentration | Standard Deviation 14.259 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 4.31 percentage of baseline concentration | Standard Deviation 3.611 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 6.33 percentage of baseline concentration | Standard Deviation 5.863 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8 | 44.45 percentage of baseline concentration | Standard Deviation 14.962 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 3.14 percentage of baseline concentration | Standard Deviation 2.932 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 11.50 percentage of baseline concentration | Standard Deviation 8.179 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 52.19 percentage of baseline concentration | Standard Deviation 16.212 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 20.17 percentage of baseline concentration | Standard Deviation 12.575 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 2.19 percentage of baseline concentration | Standard Deviation 1.297 |
| Part A1: PF-04518600 0.1mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 3.06 percentage of baseline concentration | Standard Deviation 5.099 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 45.60 percentage of baseline concentration | Standard Deviation 23.497 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 2.05 percentage of baseline concentration | Standard Deviation 1.993 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | -0.01 percentage of baseline concentration | Standard Deviation 0.146 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 2.91 percentage of baseline concentration | Standard Deviation 2.195 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 1.08 percentage of baseline concentration | Standard Deviation 0.859 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.07 percentage of baseline concentration | Standard Deviation 0.216 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 3.25 percentage of baseline concentration | Standard Deviation 2.091 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 55.18 percentage of baseline concentration | Standard Deviation 10.939 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8 | 32.47 percentage of baseline concentration | Standard Deviation 13.862 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 3.49 percentage of baseline concentration | Standard Deviation 4.759 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8 | 35.78 percentage of baseline concentration | Standard Deviation 13.922 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8 | 37.20 percentage of baseline concentration | Standard Deviation 8.902 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 3.36 percentage of baseline concentration | Standard Deviation 5.108 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 48.67 percentage of baseline concentration | Standard Deviation 8.943 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 9.00 percentage of baseline concentration | Standard Deviation 5.355 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 2.99 percentage of baseline concentration | Standard Deviation 4.632 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 34.92 percentage of baseline concentration | Standard Deviation 5.867 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 41.20 percentage of baseline concentration | Standard Deviation 20.054 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 41.23 percentage of baseline concentration | Standard Deviation 6.725 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8 | 40.53 percentage of baseline concentration | Standard Deviation 6.707 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 38.67 percentage of baseline concentration | Standard Deviation 8.521 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 36.40 percentage of baseline concentration | Standard Deviation 4.627 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 11.29 percentage of baseline concentration | Standard Deviation 13.434 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 50.53 percentage of baseline concentration | Standard Deviation 13.385 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 1.98 percentage of baseline concentration | Standard Deviation 1.096 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 41.42 percentage of baseline concentration | Standard Deviation 11.115 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 44.38 percentage of baseline concentration | Standard Deviation 9.798 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) End of treatment | 0.57 percentage of baseline concentration | Standard Deviation 0.306 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 48.54 percentage of baseline concentration | Standard Deviation 14.165 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 1.77 percentage of baseline concentration | Standard Deviation 1.966 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 2.73 percentage of baseline concentration | Standard Deviation 2.004 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 41.89 percentage of baseline concentration | Standard Deviation 10.092 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 39.07 percentage of baseline concentration | Standard Deviation 13.011 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 52.93 percentage of baseline concentration | Standard Deviation 9.347 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 35.62 percentage of baseline concentration | Standard Deviation 13.117 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) End of treatment | 0.27 percentage of baseline concentration | Standard Deviation 0.351 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 0.94 percentage of baseline concentration | Standard Deviation 1.25 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) End of treatment | 3.87 percentage of baseline concentration | Standard Deviation 5.065 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 10.19 percentage of baseline concentration | Standard Deviation 13.521 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 9.02 percentage of baseline concentration | Standard Deviation 5.27 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8 | 38.21 percentage of baseline concentration | Standard Deviation 4.342 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 35.20 percentage of baseline concentration | Standard Deviation 3.35 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 2.60 percentage of baseline concentration | Standard Deviation 1.952 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 36.67 percentage of baseline concentration | Standard Deviation 2.589 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 2.39 percentage of baseline concentration | Standard Deviation 3.102 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 5.50 percentage of baseline concentration | Standard Deviation 4.018 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) End of treatment | 0.30 percentage of baseline concentration | Standard Deviation 0.624 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 45.09 percentage of baseline concentration | Standard Deviation 11.917 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 0.01 percentage of baseline concentration | Standard Deviation 0.107 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.27 percentage of baseline concentration | Standard Deviation 0.462 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 13.42 percentage of baseline concentration | Standard Deviation 8.546 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.65 percentage of baseline concentration | Standard Deviation 0.909 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 36.97 percentage of baseline concentration | Standard Deviation 7.219 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 5.94 percentage of baseline concentration | Standard Deviation 5.734 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 9.50 percentage of baseline concentration | Standard Deviation 12.278 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 41.21 percentage of baseline concentration | Standard Deviation 9.855 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.06 percentage of baseline concentration | Standard Deviation 0.172 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 0.23 percentage of baseline concentration | Standard Deviation 0.674 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) End of treatment | -0.07 percentage of baseline concentration | Standard Deviation 0.115 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 48.00 percentage of baseline concentration | Standard Deviation 14.287 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 3.50 percentage of baseline concentration | Standard Deviation 5.568 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.04 percentage of baseline concentration | Standard Deviation 0.181 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 38.67 percentage of baseline concentration | Standard Deviation 12.438 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 0.54 percentage of baseline concentration | Standard Deviation 1.381 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 51.86 percentage of baseline concentration | Standard Deviation 9.906 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.65 percentage of baseline concentration | Standard Deviation 0.771 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 43.38 percentage of baseline concentration | Standard Deviation 23.693 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 9.03 percentage of baseline concentration | Standard Deviation 10.168 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 0.05 percentage of baseline concentration | Standard Deviation 0.105 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.19 percentage of baseline concentration | Standard Deviation 0.937 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 3.67 percentage of baseline concentration | Standard Deviation 2.511 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 3.69 percentage of baseline concentration | Standard Deviation 5.607 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.12 percentage of baseline concentration | Standard Deviation 0.164 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8 | 34.46 percentage of baseline concentration | Standard Deviation 11.679 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 46.00 percentage of baseline concentration | Standard Deviation 7.485 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 51.01 percentage of baseline concentration | Standard Deviation 14.11 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.67 percentage of baseline concentration | Standard Deviation 0.603 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 0.31 percentage of baseline concentration | Standard Deviation 0.965 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 44.85 percentage of baseline concentration | Standard Deviation 9.407 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 8.03 percentage of baseline concentration | Standard Deviation 1.528 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 3.56 percentage of baseline concentration | Standard Deviation 5.524 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 2.67 percentage of baseline concentration | Standard Deviation 2.081 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 8.65 percentage of baseline concentration | Standard Deviation 6.783 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.03 percentage of baseline concentration | Standard Deviation 0.699 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.44 percentage of baseline concentration | Standard Deviation 0.391 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) End of treatment | 28.12 percentage of baseline concentration | Standard Deviation 16.961 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) End of treatment | 21.43 percentage of baseline concentration | Standard Deviation 17.01 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 46.63 percentage of baseline concentration | Standard Deviation 22.926 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) End of treatment | 0.23 percentage of baseline concentration | Standard Deviation 0.252 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 0.53 percentage of baseline concentration | Standard Deviation 0.647 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) End of treatment | 35.60 percentage of baseline concentration | Standard Deviation 19.987 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 3.77 percentage of baseline concentration | Standard Deviation 6.125 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.17 percentage of baseline concentration | Standard Deviation 0.309 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 1.34 percentage of baseline concentration | Standard Deviation 1.646 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 10.49 percentage of baseline concentration | Standard Deviation 11.153 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | -0.46 percentage of baseline concentration | Standard Deviation 1.561 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 40.76 percentage of baseline concentration | Standard Deviation 18.801 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H)) | 0.53 percentage of baseline concentration | Standard Deviation 0.869 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 1.03 percentage of baseline concentration | Standard Deviation 2.177 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 4.83 percentage of baseline concentration | Standard Deviation 3.81 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.63 percentage of baseline concentration | Standard Deviation 1.274 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 2.70 percentage of baseline concentration | Standard Deviation 3.344 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) End of treatment | 24.80 percentage of baseline concentration | Standard Deviation 23.435 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 34.51 percentage of baseline concentration | Standard Deviation 10.649 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 33.46 percentage of baseline concentration | Standard Deviation 11.82 |
| Part A1: PF-04518600 0.3mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 1.26 percentage of baseline concentration | Standard Deviation 1.367 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 18.72 percentage of baseline concentration | Standard Deviation 14.591 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 41.53 percentage of baseline concentration | Standard Deviation 11.797 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H)) | 11.96 percentage of baseline concentration | Standard Deviation 26.576 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | -0.07 percentage of baseline concentration | Standard Deviation 0.221 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 0.30 percentage of baseline concentration | Standard Deviation 0.306 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.41 percentage of baseline concentration | Standard Deviation 0.745 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 0.04 percentage of baseline concentration | Standard Deviation 0.098 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.04 percentage of baseline concentration | Standard Deviation 0.223 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 0.04 percentage of baseline concentration | Standard Deviation 0.151 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | -0.07 percentage of baseline concentration | Standard Deviation 0.153 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.10 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) End of treatment | -0.18 percentage of baseline concentration | Standard Deviation 0.15 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 45.67 percentage of baseline concentration | Standard Deviation 12.565 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 12.92 percentage of baseline concentration | Standard Deviation 28.499 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 0.10 percentage of baseline concentration | Standard Deviation 0.238 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.66 percentage of baseline concentration | Standard Deviation 1.037 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 1.13 percentage of baseline concentration | Standard Deviation 1.908 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.23 percentage of baseline concentration | Standard Deviation 0.39 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.37 percentage of baseline concentration | Standard Deviation 0.556 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 40.88 percentage of baseline concentration | Standard Deviation 11.313 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 0.11 percentage of baseline concentration | Standard Deviation 0.393 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.13 percentage of baseline concentration | Standard Deviation 0.231 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.00 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) End of treatment | 0.15 percentage of baseline concentration | Standard Deviation 0.436 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8 | 43.15 percentage of baseline concentration | Standard Deviation 9.439 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 12.52 percentage of baseline concentration | Standard Deviation 8.946 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 3.50 percentage of baseline concentration | Standard Deviation 7.275 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 0.03 percentage of baseline concentration | Standard Deviation 1.021 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | -0.23 percentage of baseline concentration | Standard Deviation 0.699 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.31 percentage of baseline concentration | Standard Deviation 0.825 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | -0.20 percentage of baseline concentration | Standard Deviation 0.673 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | -0.26 percentage of baseline concentration | Standard Deviation 0.616 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | -0.24 percentage of baseline concentration | Standard Deviation 1.086 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | -0.03 percentage of baseline concentration | Standard Deviation 0.231 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.40 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 37.88 percentage of baseline concentration | Standard Deviation 11.844 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8 | 38.61 percentage of baseline concentration | Standard Deviation 13.391 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 32.20 percentage of baseline concentration | Standard Deviation 7.105 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 25.70 percentage of baseline concentration | Standard Deviation 9.051 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) End of treatment | 38.10 percentage of baseline concentration | Standard Deviation 10.006 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) End of treatment | -0.27 percentage of baseline concentration | Standard Deviation 1.396 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 45.35 percentage of baseline concentration | Standard Deviation 13.3 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 51.86 percentage of baseline concentration | Standard Deviation 10.272 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 39.77 percentage of baseline concentration | Standard Deviation 12.347 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 45.09 percentage of baseline concentration | Standard Deviation 10.489 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 45.70 percentage of baseline concentration | Standard Deviation 10.567 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 41.00 percentage of baseline concentration | Standard Deviation 12.981 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 42.94 percentage of baseline concentration | Standard Deviation 11.357 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 42.87 percentage of baseline concentration | Standard Deviation 10.049 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 43.43 percentage of baseline concentration | Standard Deviation 5.788 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 4.57 percentage of baseline concentration | Standard Deviation 2.953 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 39.90 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) End of treatment | 41.38 percentage of baseline concentration | Standard Deviation 6.111 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 47.03 percentage of baseline concentration | Standard Deviation 13.816 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 47.82 percentage of baseline concentration | Standard Deviation 15.437 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 37.09 percentage of baseline concentration | Standard Deviation 14.705 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 44.00 percentage of baseline concentration | Standard Deviation 13.558 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 44.06 percentage of baseline concentration | Standard Deviation 12.694 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 43.93 percentage of baseline concentration | Standard Deviation 14.824 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 43.71 percentage of baseline concentration | Standard Deviation 14.276 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 1.40 percentage of baseline concentration | Standard Deviation 2.859 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 42.40 percentage of baseline concentration | Standard Deviation 13.966 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 51.03 percentage of baseline concentration | Standard Deviation 10.119 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 44.80 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) End of treatment | 29.83 percentage of baseline concentration | Standard Deviation 12.258 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 16.30 percentage of baseline concentration | Standard Deviation 11.546 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 12.27 percentage of baseline concentration | Standard Deviation 10.298 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 0.04 percentage of baseline concentration | Standard Deviation 0.151 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 15.81 percentage of baseline concentration | Standard Deviation 9.926 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 14.83 percentage of baseline concentration | Standard Deviation 11.588 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 12.89 percentage of baseline concentration | Standard Deviation 8.212 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 14.19 percentage of baseline concentration | Standard Deviation 9.905 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 13.90 percentage of baseline concentration | Standard Deviation 8.309 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 13.60 percentage of baseline concentration | Standard Deviation 10.942 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.03 percentage of baseline concentration | Standard Deviation 0.198 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 21.60 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.01 percentage of baseline concentration | Standard Deviation 0.09 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) End of treatment | 15.08 percentage of baseline concentration | Standard Deviation 12.687 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 5.35 percentage of baseline concentration | Standard Deviation 4.7 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 4.86 percentage of baseline concentration | Standard Deviation 5.229 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.06 percentage of baseline concentration | Standard Deviation 0.127 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 3.57 percentage of baseline concentration | Standard Deviation 4.13 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 4.50 percentage of baseline concentration | Standard Deviation 4.727 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | -0.01 percentage of baseline concentration | Standard Deviation 0.135 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 4.53 percentage of baseline concentration | Standard Deviation 4.511 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 4.06 percentage of baseline concentration | Standard Deviation 4.008 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 4.33 percentage of baseline concentration | Standard Deviation 3.693 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 4.57 percentage of baseline concentration | Standard Deviation 4.34 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 8.23 percentage of baseline concentration | Standard Deviation 4.9 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | -0.06 percentage of baseline concentration | Standard Deviation 0.113 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 7.80 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) End of treatment | 1.95 percentage of baseline concentration | Standard Deviation 1.605 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 41.20 percentage of baseline concentration | Standard Deviation 16.148 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8 | 44.29 percentage of baseline concentration | Standard Deviation 11.058 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 45.23 percentage of baseline concentration | Standard Deviation 11.181 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8 | 46.71 percentage of baseline concentration | Standard Deviation 10.444 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 42.36 percentage of baseline concentration | Standard Deviation 9.707 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8 | 41.69 percentage of baseline concentration | Standard Deviation 10.489 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | -0.07 percentage of baseline concentration | Standard Deviation 0.115 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 35.78 percentage of baseline concentration | Standard Deviation 10.316 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 28.70 percentage of baseline concentration | Standard Deviation 0.849 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) End of treatment | 43.94 percentage of baseline concentration | Standard Deviation 10.685 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.20 percentage of baseline concentration | — |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) End of treatment | -0.05 percentage of baseline concentration | Standard Deviation 0.058 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 42.13 percentage of baseline concentration | Standard Deviation 18.565 |
| Part A1: PF-04518600 1.5mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8 | 42.89 percentage of baseline concentration | Standard Deviation 13.179 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 10.38 percentage of baseline concentration | Standard Deviation 10.295 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 0.44 percentage of baseline concentration | Standard Deviation 1.043 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 12.07 percentage of baseline concentration | Standard Deviation 12.36 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 41.98 percentage of baseline concentration | Standard Deviation 12.16 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.93 percentage of baseline concentration | Standard Deviation 2.647 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 37.22 percentage of baseline concentration | Standard Deviation 19.773 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) End of treatment | 3.55 percentage of baseline concentration | Standard Deviation 5.445 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 34.40 percentage of baseline concentration | Standard Deviation 17.363 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 46.00 percentage of baseline concentration | Standard Deviation 11.665 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 11.97 percentage of baseline concentration | Standard Deviation 12.051 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 45.17 percentage of baseline concentration | Standard Deviation 16.509 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 38.22 percentage of baseline concentration | Standard Deviation 20.166 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) End of treatment | 9.90 percentage of baseline concentration | Standard Deviation 13.576 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 45.11 percentage of baseline concentration | Standard Deviation 21.747 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 1.37 percentage of baseline concentration | Standard Deviation 3.3 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.56 percentage of baseline concentration | Standard Deviation 0.94 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 3.82 percentage of baseline concentration | Standard Deviation 3.207 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 44.77 percentage of baseline concentration | Standard Deviation 24.667 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 52.28 percentage of baseline concentration | Standard Deviation 16.746 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 1.90 percentage of baseline concentration | Standard Deviation 3.897 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 2.80 percentage of baseline concentration | Standard Deviation 3.454 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) End of treatment | 45.20 percentage of baseline concentration | Standard Deviation 10.611 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 45.23 percentage of baseline concentration | Standard Deviation 9.955 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 43.40 percentage of baseline concentration | Standard Deviation 5.145 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 3.14 percentage of baseline concentration | Standard Deviation 3.347 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.88 percentage of baseline concentration | Standard Deviation 2.08 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 41.88 percentage of baseline concentration | Standard Deviation 12.275 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8 | 41.61 percentage of baseline concentration | Standard Deviation 11.904 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 2.57 percentage of baseline concentration | Standard Deviation 3.222 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 44.57 percentage of baseline concentration | Standard Deviation 13.038 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 4.63 percentage of baseline concentration | Standard Deviation 8.372 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 0.24 percentage of baseline concentration | Standard Deviation 0.72 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 0.44 percentage of baseline concentration | Standard Deviation 1.205 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 3.12 percentage of baseline concentration | Standard Deviation 3.539 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.32 percentage of baseline concentration | Standard Deviation 0.939 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 1.52 percentage of baseline concentration | Standard Deviation 3.702 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H)) | 0.40 percentage of baseline concentration | Standard Deviation 1.047 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 4.16 percentage of baseline concentration | Standard Deviation 5.786 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 1.20 percentage of baseline concentration | Standard Deviation 3.333 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8 | 52.44 percentage of baseline concentration | Standard Deviation 5.264 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 1.67 percentage of baseline concentration | Standard Deviation 4.089 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) End of treatment | 48.57 percentage of baseline concentration | Standard Deviation 7.596 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 3.14 percentage of baseline concentration | Standard Deviation 3.884 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 1.13 percentage of baseline concentration | Standard Deviation 3.862 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 3.64 percentage of baseline concentration | Standard Deviation 3.832 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 0.17 percentage of baseline concentration | Standard Deviation 0.836 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 1.13 percentage of baseline concentration | Standard Deviation 1.997 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 1.13 percentage of baseline concentration | Standard Deviation 1.966 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 0.86 percentage of baseline concentration | Standard Deviation 1.596 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 3.33 percentage of baseline concentration | Standard Deviation 5.024 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 8.95 percentage of baseline concentration | Standard Deviation 6.649 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) End of treatment | 0.50 percentage of baseline concentration | Standard Deviation 0.424 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.88 percentage of baseline concentration | Standard Deviation 1.881 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 3.67 percentage of baseline concentration | Standard Deviation 5.755 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.37 percentage of baseline concentration | Standard Deviation 0.635 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) End of treatment | 1.25 percentage of baseline concentration | Standard Deviation 1.061 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.17 percentage of baseline concentration | Standard Deviation 0.289 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 0.18 percentage of baseline concentration | Standard Deviation 0.349 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 0.70 percentage of baseline concentration | Standard Deviation 1.724 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 46.55 percentage of baseline concentration | Standard Deviation 10.978 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 45.69 percentage of baseline concentration | Standard Deviation 6.95 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 0.16 percentage of baseline concentration | Standard Deviation 0.422 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 48.45 percentage of baseline concentration | Standard Deviation 18.597 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8 | 44.80 percentage of baseline concentration | Standard Deviation 7.508 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.14 percentage of baseline concentration | Standard Deviation 0.385 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.58 percentage of baseline concentration | Standard Deviation 0.697 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) End of treatment | 1.00 percentage of baseline concentration | Standard Deviation 1.414 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 49.74 percentage of baseline concentration | Standard Deviation 10.086 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.42 percentage of baseline concentration | Standard Deviation 0.624 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 0.01 percentage of baseline concentration | Standard Deviation 0.107 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8 | 56.66 percentage of baseline concentration | Standard Deviation 12.388 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.13 percentage of baseline concentration | Standard Deviation 0.333 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 0.10 percentage of baseline concentration | Standard Deviation 0.469 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 50.30 percentage of baseline concentration | Standard Deviation 10.907 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 42.72 percentage of baseline concentration | Standard Deviation 9.957 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) End of treatment | 0.85 percentage of baseline concentration | Standard Deviation 1.061 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8 | 40.23 percentage of baseline concentration | Standard Deviation 8.245 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) End of treatment | 36.80 percentage of baseline concentration | Standard Deviation 12.869 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 22.10 percentage of baseline concentration | Standard Deviation 18.857 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 29.60 percentage of baseline concentration | Standard Deviation 7.754 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 2.40 percentage of baseline concentration | Standard Deviation 4.244 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 12.82 percentage of baseline concentration | Standard Deviation 4.961 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.57 percentage of baseline concentration | Standard Deviation 1.537 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 41.88 percentage of baseline concentration | Standard Deviation 16.112 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 10.03 percentage of baseline concentration | Standard Deviation 8.477 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 35.08 percentage of baseline concentration | Standard Deviation 19.484 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 11.93 percentage of baseline concentration | Standard Deviation 8.826 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 0.80 percentage of baseline concentration | Standard Deviation 1.386 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 0.41 percentage of baseline concentration | Standard Deviation 1.057 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 33.48 percentage of baseline concentration | Standard Deviation 21.662 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 35.20 percentage of baseline concentration | Standard Deviation 14.024 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 9.55 percentage of baseline concentration | Standard Deviation 7.987 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 3.15 percentage of baseline concentration | Standard Deviation 2.473 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8 | 47.16 percentage of baseline concentration | Standard Deviation 13.427 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 10.42 percentage of baseline concentration | Standard Deviation 7.695 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 31.87 percentage of baseline concentration | Standard Deviation 18.013 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 31.91 percentage of baseline concentration | Standard Deviation 17.122 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 31.28 percentage of baseline concentration | Standard Deviation 15.021 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 40.25 percentage of baseline concentration | Standard Deviation 12.277 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) End of treatment | 34.65 percentage of baseline concentration | Standard Deviation 11.526 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.57 percentage of baseline concentration | Standard Deviation 1.069 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 9.86 percentage of baseline concentration | Standard Deviation 9.571 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 27.27 percentage of baseline concentration | Standard Deviation 23.2 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 10.34 percentage of baseline concentration | Standard Deviation 8.769 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 30.37 percentage of baseline concentration | Standard Deviation 15.309 |
| Part A1: PF-04518600 3.0mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 39.30 percentage of baseline concentration | Standard Deviation 13.509 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 2.77 percentage of baseline concentration | Standard Deviation 3.109 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | -0.00 percentage of baseline concentration | Standard Deviation 0.408 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 41.58 percentage of baseline concentration | Standard Deviation 15.879 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 15.23 percentage of baseline concentration | Standard Deviation 15.784 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | -0.20 percentage of baseline concentration | Standard Deviation 0.141 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 47.60 percentage of baseline concentration | Standard Deviation 12.181 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8 | 39.93 percentage of baseline concentration | Standard Deviation 16.671 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 6.20 percentage of baseline concentration | Standard Deviation 4.525 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 49.00 percentage of baseline concentration | Standard Deviation 27.294 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 18.67 percentage of baseline concentration | Standard Deviation 27.05 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 32.15 percentage of baseline concentration | Standard Deviation 19.304 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | -0.27 percentage of baseline concentration | Standard Deviation 0.379 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.08 percentage of baseline concentration | Standard Deviation 0.222 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | 3.00 percentage of baseline concentration | Standard Deviation 1.9 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.28 percentage of baseline concentration | Standard Deviation 0.457 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8 | 37.37 percentage of baseline concentration | Standard Deviation 16.783 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 42.35 percentage of baseline concentration | Standard Deviation 21.708 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 49.25 percentage of baseline concentration | Standard Deviation 15.295 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 18.73 percentage of baseline concentration | Standard Deviation 18.566 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 4.75 percentage of baseline concentration | Standard Deviation 3.041 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 35.65 percentage of baseline concentration | Standard Deviation 31.183 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | -0.10 percentage of baseline concentration | Standard Deviation 0 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8 | 10.65 percentage of baseline concentration | Standard Deviation 15.91 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.00 percentage of baseline concentration | Standard Deviation 0.082 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 31.60 percentage of baseline concentration | Standard Deviation 21.458 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 2.60 percentage of baseline concentration | Standard Deviation 0.99 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | 23.27 percentage of baseline concentration | Standard Deviation 26.999 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 46.75 percentage of baseline concentration | Standard Deviation 19.728 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.15 percentage of baseline concentration | Standard Deviation 0.071 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 7.23 percentage of baseline concentration | Standard Deviation 8.066 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 6.30 percentage of baseline concentration | Standard Deviation 2.263 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 23.30 percentage of baseline concentration | Standard Deviation 11.811 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 55.70 percentage of baseline concentration | Standard Deviation 14.001 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | -0.25 percentage of baseline concentration | Standard Deviation 0.354 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | 27.70 percentage of baseline concentration | Standard Deviation 13.124 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 35.40 percentage of baseline concentration | Standard Deviation 46.528 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | -0.20 percentage of baseline concentration | Standard Deviation 0.424 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 38.43 percentage of baseline concentration | Standard Deviation 6.543 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 21.00 percentage of baseline concentration | Standard Deviation 4.101 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8 | 0.00 percentage of baseline concentration | Standard Deviation 0.1 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H) | 36.05 percentage of baseline concentration | Standard Deviation 16.733 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | -0.15 percentage of baseline concentration | Standard Deviation 0.071 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 0.00 percentage of baseline concentration | Standard Deviation 0.1 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H)) | -0.25 percentage of baseline concentration | Standard Deviation 0.507 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.15 percentage of baseline concentration | Standard Deviation 0.071 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 24.48 percentage of baseline concentration | Standard Deviation 26.779 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8 | -0.00 percentage of baseline concentration | Standard Deviation 0.294 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 33.23 percentage of baseline concentration | Standard Deviation 16.607 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 38.68 percentage of baseline concentration | Standard Deviation 19.538 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | -0.60 percentage of baseline concentration | Standard Deviation 0.707 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 33.43 percentage of baseline concentration | Standard Deviation 10.754 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 38.35 percentage of baseline concentration | Standard Deviation 9.019 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | -0.03 percentage of baseline concentration | Standard Deviation 0.115 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 22.53 percentage of baseline concentration | Standard Deviation 26.873 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose) | 59.75 percentage of baseline concentration | Standard Deviation 12.092 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 48.25 percentage of baseline concentration | Standard Deviation 12.799 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | -0.10 percentage of baseline concentration | Standard Deviation 0 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 33.40 percentage of baseline concentration | Standard Deviation 30.83 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose) | 35.85 percentage of baseline concentration | Standard Deviation 0.354 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose) | 52.35 percentage of baseline concentration | Standard Deviation 15.344 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose) | 41.18 percentage of baseline concentration | Standard Deviation 8.761 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2 | 23.95 percentage of baseline concentration | Standard Deviation 34.295 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.07 percentage of baseline concentration | Standard Deviation 0.153 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2 | 11.70 percentage of baseline concentration | Standard Deviation 15.839 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | -0.05 percentage of baseline concentration | Standard Deviation 0.071 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8 | 41.10 percentage of baseline concentration | Standard Deviation 15.125 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H) | 0.08 percentage of baseline concentration | Standard Deviation 0.05 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8 | -0.03 percentage of baseline concentration | Standard Deviation 0.058 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | 24.25 percentage of baseline concentration | Standard Deviation 19.728 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8 | 17.88 percentage of baseline concentration | Standard Deviation 20.99 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose) | 39.25 percentage of baseline concentration | Standard Deviation 20.718 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 30.40 percentage of baseline concentration | Standard Deviation 12.382 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | -0.45 percentage of baseline concentration | Standard Deviation 0.212 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8 | 42.40 percentage of baseline concentration | Standard Deviation 7.165 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 8 | -0.87 percentage of baseline concentration | Standard Deviation 0.681 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8 | 0.30 percentage of baseline concentration | Standard Deviation 0.458 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose) | 15.63 percentage of baseline concentration | Standard Deviation 20.503 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | -0.03 percentage of baseline concentration | Standard Deviation 0.153 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | -0.10 percentage of baseline concentration | Standard Deviation 0.173 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8 | 41.70 percentage of baseline concentration | Standard Deviation 13.089 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | -0.25 percentage of baseline concentration | Standard Deviation 0.212 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 13.10 percentage of baseline concentration | Standard Deviation 19.341 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | -0.40 percentage of baseline concentration | Standard Deviation 0.707 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8 | 0.08 percentage of baseline concentration | Standard Deviation 0.222 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 8 | 0.50 percentage of baseline concentration | Standard Deviation 0.6 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8 | 31.67 percentage of baseline concentration | Standard Deviation 18.151 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose) | 0.20 percentage of baseline concentration | Standard Deviation 0.283 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8 | 19.07 percentage of baseline concentration | Standard Deviation 30.641 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose) | 40.57 percentage of baseline concentration | Standard Deviation 3.415 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8 | 35.77 percentage of baseline concentration | Standard Deviation 14.935 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8 | 40.55 percentage of baseline concentration | Standard Deviation 9.219 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | -0.20 percentage of baseline concentration | Standard Deviation 0.985 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2 | -0.05 percentage of baseline concentration | Standard Deviation 0.071 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose) | 2.67 percentage of baseline concentration | Standard Deviation 1.57 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2 | 0.10 percentage of baseline concentration | Standard Deviation 0.141 |
| Part A1: PF-04518600 10mg/kg | Mean Unbound Cell Surface OX40 in Part A1 | Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose) | 30.45 percentage of baseline concentration | Standard Deviation 38.537 |
Secondary
Number of Participants Having SD in Part B
SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants Having SD in Part B | 2 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants Having SD in Part B | 5 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants Having SD in Part B | 4 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants Having SD in Part B | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants Having SD in Part B | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants Having SD in Part B | 14 Participants |
Secondary
Number of Participants Having Stable Disease (SD) in Part A
SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants Having Stable Disease (SD) in Part A | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants Having Stable Disease (SD) in Part A | 5 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants Having Stable Disease (SD) in Part A | 6 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants Having Stable Disease (SD) in Part A | 6 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants Having Stable Disease (SD) in Part A | 8 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants Having Stable Disease (SD) in Part A | 1 Participants |
| Part A2: PF-04518600 30mg | Number of Participants Having Stable Disease (SD) in Part A | 9 Participants |
| Part A2: PF-04518600 250mg | Number of Participants Having Stable Disease (SD) in Part A | 10 Participants |
Secondary
Number of Participants With ADA and NAb Against PF-04518600 in Part B
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
Time frame: Baseline up to end of treatment (maximum of 14 weeks).
Population: The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | ADA ever-positive | 6 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | NAb ever-positive | 1 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | ADA ever-positive | 5 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | ADA ever-positive | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | NAb ever-positive | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | ADA ever-positive | 1 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | ADA ever-positive | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | ADA ever-positive | 13 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With ADA and NAb Against PF-04518600 in Part B | NAb ever-positive | 0 Participants |
Secondary
Number of Participants With ADA and NAb Against Utomilumab in Part B
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
Time frame: Baseline up to end of treatment (maximum of 14 weeks).
Population: The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | ADA ever-positive | 5 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | NAb ever-positive | 4 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | ADA ever-positive | 9 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | NAb ever-positive | 6 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | ADA ever-positive | 9 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | NAb ever-positive | 7 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | ADA ever-positive | 5 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | NAb ever-positive | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | ADA ever-positive | 4 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | NAb ever-positive | 3 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | ADA ever-positive | 22 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With ADA and NAb Against Utomilumab in Part B | NAb ever-positive | 22 Participants |
Secondary
Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A
ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.
Time frame: Baseline up to end of treatment (maximum of 14 weeks).
Population: The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 2 Participants |
| Part A1: PF-04518600 0.01mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 9 Participants |
| Part A1: PF-04518600 0.1mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 3 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 5 Participants |
| Part A1: PF-04518600 0.3mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 2 Participants |
| Part A1: PF-04518600 1.5mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 0 Participants |
| Part A1: PF-04518600 3.0mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 0 Participants |
| Part A1: PF-04518600 10mg/kg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 0 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 2 Participants |
| Part A2: PF-04518600 30mg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 7 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | ADA ever-positive | 0 Participants |
| Part A2: PF-04518600 250mg | Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A | NAb ever-positive | 0 Participants |
Secondary
Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A
ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set. CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \<10 mm. PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 0 percentage of participants |
| Part A1: PF-04518600 0.01mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 0 percentage of participants |
| Part A1: PF-04518600 0.1mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 10 percentage of participants |
| Part A1: PF-04518600 0.1mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 10 percentage of participants |
| Part A1: PF-04518600 0.3mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 9.1 percentage of participants |
| Part A1: PF-04518600 0.3mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 9.1 percentage of participants |
| Part A1: PF-04518600 1.5mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 0 percentage of participants |
| Part A1: PF-04518600 1.5mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 0 percentage of participants |
| Part A1: PF-04518600 3.0mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 0 percentage of participants |
| Part A1: PF-04518600 3.0mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 0 percentage of participants |
| Part A1: PF-04518600 10mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 25 percentage of participants |
| Part A1: PF-04518600 10mg/kg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 25 percentage of participants |
| Part A2: PF-04518600 30mg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 0 percentage of participants |
| Part A2: PF-04518600 30mg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 0 percentage of participants |
| Part A2: PF-04518600 250mg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per RECIST v1.1 | 0 percentage of participants |
| Part A2: PF-04518600 250mg | Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A | ORR per irRECIST | 0 percentage of participants |
Secondary
ORR Assessed by RECIST Version 1.1 and irRECIST in Part B
ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set. CR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \<10 mm. PR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per RECIST v1.1 | 0 Percentage of participants |
| Part A1: PF-04518600 0.01mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per irRECIST | 0 Percentage of participants |
| Part A1: PF-04518600 0.1mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per RECIST v1.1 | 8.3 Percentage of participants |
| Part A1: PF-04518600 0.1mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per irRECIST | 8.3 Percentage of participants |
| Part A1: PF-04518600 0.3mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per RECIST v1.1 | 8.3 Percentage of participants |
| Part A1: PF-04518600 0.3mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per irRECIST | 8.3 Percentage of participants |
| Part A1: PF-04518600 1.5mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per RECIST v1.1 | 0 Percentage of participants |
| Part A1: PF-04518600 1.5mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per irRECIST | 0 Percentage of participants |
| Part A1: PF-04518600 3.0mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per RECIST v1.1 | 0 Percentage of participants |
| Part A1: PF-04518600 3.0mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per irRECIST | 0 Percentage of participants |
| Part A1: PF-04518600 10mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per RECIST v1.1 | 3.3 Percentage of participants |
| Part A1: PF-04518600 10mg/kg | ORR Assessed by RECIST Version 1.1 and irRECIST in Part B | ORR per irRECIST | 3.3 Percentage of participants |
Secondary
Overall Survival Rates at Months 6, 12, and 24 in Part A
Probability of survival at 6, 12, and 24 months after the first dose of study treatment.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 100 Probability of survival |
| Part A1: PF-04518600 0.01mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | NA Probability of survival |
| Part A1: PF-04518600 0.01mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 50.0 Probability of survival |
| Part A1: PF-04518600 0.1mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | NA Probability of survival |
| Part A1: PF-04518600 0.1mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 51.4 Probability of survival |
| Part A1: PF-04518600 0.1mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 68.6 Probability of survival |
| Part A1: PF-04518600 0.3mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | 44.4 Probability of survival |
| Part A1: PF-04518600 0.3mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 88.9 Probability of survival |
| Part A1: PF-04518600 0.3mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 55.6 Probability of survival |
| Part A1: PF-04518600 1.5mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 75.0 Probability of survival |
| Part A1: PF-04518600 1.5mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 41.7 Probability of survival |
| Part A1: PF-04518600 1.5mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | NA Probability of survival |
| Part A1: PF-04518600 3.0mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 33.8 Probability of survival |
| Part A1: PF-04518600 3.0mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 67.7 Probability of survival |
| Part A1: PF-04518600 3.0mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | 16.9 Probability of survival |
| Part A1: PF-04518600 10mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 50.0 Probability of survival |
| Part A1: PF-04518600 10mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 50.0 Probability of survival |
| Part A1: PF-04518600 10mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | 25.0 Probability of survival |
| Part A2: PF-04518600 30mg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 54.7 Probability of survival |
| Part A2: PF-04518600 30mg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 62.5 Probability of survival |
| Part A2: PF-04518600 30mg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | 27.3 Probability of survival |
| Part A2: PF-04518600 250mg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 6 | 83.9 Probability of survival |
| Part A2: PF-04518600 250mg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 12 | 58.4 Probability of survival |
| Part A2: PF-04518600 250mg | Overall Survival Rates at Months 6, 12, and 24 in Part A | Survival Probability at Month 24 | 42.6 Probability of survival |
Secondary
Overall Survival Rates at Months 6, 12, and 24 in Part B
Probability of survival at 6, 12, and 24 months after the first dose of study treatment.
Time frame: Baseline up to 24 months post first dose.
Population: Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 12 | 30.7 Probability of survival |
| Part A1: PF-04518600 0.01mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 6 | 61.4 Probability of survival |
| Part A1: PF-04518600 0.01mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 24 | 10.2 Probability of survival |
| Part A1: PF-04518600 0.1mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 12 | 36.8 Probability of survival |
| Part A1: PF-04518600 0.1mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 6 | 61.4 Probability of survival |
| Part A1: PF-04518600 0.1mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 24 | 12.3 Probability of survival |
| Part A1: PF-04518600 0.3mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 12 | 51.9 Probability of survival |
| Part A1: PF-04518600 0.3mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 6 | 72.7 Probability of survival |
| Part A1: PF-04518600 0.3mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 24 | 20.8 Probability of survival |
| Part A1: PF-04518600 1.5mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 12 | 43.8 Probability of survival |
| Part A1: PF-04518600 1.5mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 6 | 58.4 Probability of survival |
| Part A1: PF-04518600 1.5mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 24 | NA Probability of survival |
| Part A1: PF-04518600 3.0mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 12 | 11.3 Probability of survival |
| Part A1: PF-04518600 3.0mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 6 | 45.0 Probability of survival |
| Part A1: PF-04518600 3.0mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 24 | 11.3 Probability of survival |
| Part A1: PF-04518600 10mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 6 | 63.9 Probability of survival |
| Part A1: PF-04518600 10mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 24 | 6.7 Probability of survival |
| Part A1: PF-04518600 10mg/kg | Overall Survival Rates at Months 6, 12, and 24 in Part B | Survival Probability at Month 12 | 51.9 Probability of survival |
Secondary
Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.374 ratio | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 0.1mg/kg | Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.593 ratio | Geometric Coefficient of Variation 26 |
| Part A1: PF-04518600 0.3mg/kg | Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.762 ratio | Geometric Coefficient of Variation 12 |
| Part A1: PF-04518600 1.5mg/kg | Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.361 ratio | Geometric Coefficient of Variation 37 |
| Part A1: PF-04518600 3.0mg/kg | Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.861 ratio | Geometric Coefficient of Variation 31 |
| Part A1: PF-04518600 10mg/kg | Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B | 1.413 ratio | Geometric Coefficient of Variation 31 |
Secondary
Rac of Utomilumab Following Multiple Doses on C3D1 in Part B
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | NA ratio | — |
| Part A1: PF-04518600 0.1mg/kg | Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.5441 ratio | Geometric Coefficient of Variation 120 |
| Part A1: PF-04518600 0.3mg/kg | Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | 1.091 ratio | Geometric Coefficient of Variation 69 |
| Part A1: PF-04518600 1.5mg/kg | Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.2673 ratio | Geometric Coefficient of Variation 1381 |
| Part A1: PF-04518600 3.0mg/kg | Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.9041 ratio | Geometric Coefficient of Variation 26 |
| Part A1: PF-04518600 10mg/kg | Rac of Utomilumab Following Multiple Doses on C3D1 in Part B | 0.391 ratio | Geometric Coefficient of Variation 886 |
Secondary
t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 4.104 days | Standard Deviation 1.2263 |
| Part A1: PF-04518600 0.01mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA days | — |
| Part A1: PF-04518600 0.1mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | NA days | — |
| Part A1: PF-04518600 0.3mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | NA days | — |
| Part A1: PF-04518600 1.5mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 4.72 days | — |
| Part A1: PF-04518600 3.0mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 5.61 days | — |
| Part A1: PF-04518600 10mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 3.87 days | — |
| Part A1: PF-04518600 10mg/kg | t1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 5.260 days | Standard Deviation 0.76772 |
Secondary
t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 5.25 days | — |
| Part A1: PF-04518600 0.01mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 11.37 days | Standard Deviation 0.58595 |
| Part A1: PF-04518600 0.1mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 5.44 days | — |
| Part A1: PF-04518600 0.3mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 7.769 days | Standard Deviation 2.2299 |
| Part A1: PF-04518600 1.5mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | 2.59 days | — |
| Part A1: PF-04518600 1.5mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 6.873 days | Standard Deviation 1.9954 |
| Part A1: PF-04518600 3.0mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 8.27 days | Standard Deviation 2.2945 |
| Part A1: PF-04518600 3.0mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA days | — |
| Part A1: PF-04518600 10mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE3/DAY1 | NA days | — |
| Part A1: PF-04518600 10mg/kg | t1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B | CYCLE1/DAY1 | 6.632 days | Standard Deviation 2.5566 |
Secondary
Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A
t1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.
Time frame: For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A1: PF-04518600 0.1mg/kg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 4.010 days | Standard Deviation 1.137 |
| Part A1: PF-04518600 0.1mg/kg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 3.410 days | Standard Deviation 1.0992 |
| Part A1: PF-04518600 0.3mg/kg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | NA days | — |
| Part A1: PF-04518600 3.0mg/kg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 10.6 days | — |
| Part A1: PF-04518600 3.0mg/kg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 13.1 days | — |
| Part A2: PF-04518600 30mg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 5.67 days | Standard Deviation 5.89 |
| Part A2: PF-04518600 30mg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 5.76 days | — |
| Part A2: PF-04518600 250mg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE3/DAY1 | 11.9 days | — |
| Part A2: PF-04518600 250mg | Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A | CYCLE1/DAY1 | 11.9 days | — |
Secondary
Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B
Vss was defined as volume of distribution at steady state.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B | NA mL/kg |
| Part A1: PF-04518600 1.5mg/kg | Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B | 67.4 mL/kg |
| Part A1: PF-04518600 10mg/kg | Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B | 54.3 mL/kg |
Secondary
Vss of Utomilumab Following Multiple Doses on C3D1 in Part B
Vss was defined as volume of distribution at steady state.
Time frame: For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.
Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A1: PF-04518600 0.01mg/kg | Vss of Utomilumab Following Multiple Doses on C3D1 in Part B | 6.7 mL/kg |
| Part A1: PF-04518600 1.5mg/kg | Vss of Utomilumab Following Multiple Doses on C3D1 in Part B | 4.22 mL/kg |
| Part A1: PF-04518600 3.0mg/kg | Vss of Utomilumab Following Multiple Doses on C3D1 in Part B | NA mL/kg |
| Part A1: PF-04518600 10mg/kg | Vss of Utomilumab Following Multiple Doses on C3D1 in Part B | NA mL/kg |