Focal Segmental Glomerulosclerosis (FSGS)
Conditions
Keywords
Proteinuria
Brief summary
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.
Interventions
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.
Sponsors
Study design
Masking description
Open label
Eligibility
Inclusion criteria
1. Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS. 2. Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate \< 50% tubulointerstitial fibrosis. 3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening. 4. Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment.
Exclusion criteria
1. Diagnosis of collapsing FSGS. 2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis. 3. Organ transplant. 4. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years. 5. Body mass index (BMI) greater than 45 kg/m2. 6. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13 | Baseline, Week 13 | UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormalities in Laboratory Test Parameters | From Day 1 of treatment up to Week 33 | Hemoglobin (Hg), hematocrit, erythrocytes: \<0.8\*lower limits of normal (LLN); platelets: \<0.5\*LLN\>1.75\*upper limits of normal(ULN); leukocytes (leu), glucose-fasting:\<0.6\*LLN\>1.5\*ULN; lymphocytes (lym), lym/leu, neutrophils(neu),neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: \<0.8\*LLN\>1.2\*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: \>1.2\*ULN; bilirubin (total, direct, indirect):\>1.5\*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol (total,LDL,HDL),triglycerides, Hg A1C: \>1.3\*ULN; sodium: \<0.95\*LLN\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLLN\>1.1\*ULN; prolactin: \>1.1\*ULN; creatine kinase: \>2.0\*ULN; urobilinogen: \>=1; Urine-specific gravity: \<1.003\>1.030, pH: \<4.5 \>8, glucose,protein,bilirubin,nitrite,leukocyte esterase, ketones: \>=1.Categories with at-least 1 non-zero values are reported. |
| Change From Baseline in Body Weight | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 | Change from baseline in body weight and at baseline values were reported for this outcome measure. |
| Change From Baseline in Blood Pressure | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 | Change from baseline in blood pressure and at baseline values were reported for this outcome measure. |
| Change From Baseline in Pulse Rate | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 | Change from baseline in pulse rate and at baseline values were reported for this outcome measure. |
| Change From Baseline in Body Temperature | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 | Change from baseline in body temperature and at baseline values were reported for this outcome measure. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33) | An adverse event was considered treatment emergent relative to a given treatment if the event occurred for the first time during the investigational treatment period and was not seen prior to the start of treatment (during the lead-in period), or the event was seen prior to the start of treatment but increased in severity during treatment. Adverse events occurring during the lead-in period were considered non-treatment emergent. Events that occurred during the follow-Up period were counted as treatment emergent and attributed to the previous treatment taken. |
| Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Baseline, Weeks 2, 5, 9 and 13 | UPCR is a ratio between two measured substances in urine: mmol of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. |
| Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Baseline, Weeks 3, 5, 9 and 13 | The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration, age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) = 175\*(sCr/88.4)\^-1.154\*(Age)\^-0.203\*(0.742 if female)\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). For Baseline eGFR, the Low eGFR group was defined as baseline eGFR \< 45 mL/min/1.73m2, and the High eGFR group was defined as baseline eGFR \> 45 mL/min/1.73 m2. |
| Serum PF-06730512 Concentration Versus Time Summary | For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT) | — |
| Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) | From Day 1 of treatment up to Week 33 | Number of participants with positive ADA and/or NAb were reported for this outcome measure. |
| Number of Participants With Abnormalities in Electrocardiogram (ECG) | Weeks 3, 7, 11, 13, 17, 21, 25, 33 | ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (\>) 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 3) Heart rate (bpm): RR decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100; RR (interval between 2 successive R waves on ECG) increase \>25% and to a VR \<50; 4) Pulse rate (msec): increase \>25% and to a value \>200; 5) QT (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 6) QRS (msec): increase \>25% and to a value \>110. Categories (timepoints) with at least 1 participant having ECG abnormality in any of the reporting arms, were reported for this outcome measure. |
Countries
Canada, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Slovakia, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 47 participants were enrolled into the study. All participants received treatment.
Participants by arm
| Arm | Count |
|---|---|
| PF-06730512 1000 mg IV Participants received PF-06730512 1000 mg IV Q2W. | 23 |
| PF-06730512 300 mg IV Participants received PF-06730512 300 mg IV Q2W. | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Investigational Treatment Period:Upto24W | Adverse Event | 1 | 0 |
| Investigational Treatment Period:Upto24W | Lack of Efficacy | 0 | 1 |
| Investigational Treatment Period:Upto24W | Physician's decision | 0 | 1 |
| Investigational Treatment Period:Upto24W | Study terminated by sponsor | 0 | 5 |
| Investigational Treatment Period:Upto24W | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | PF-06730512 1000 mg IV | PF-06730512 300 mg IV | Total |
|---|---|---|---|
| Age, Continuous | 42.7 Years STANDARD_DEVIATION 13.64 | 41.0 Years STANDARD_DEVIATION 14.6 | 41.8 Years STANDARD_DEVIATION 14.01 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 21 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 16 Participants | 36 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 24 |
| other Total, other adverse events | 11 / 23 | 12 / 24 |
| serious Total, serious adverse events | 2 / 23 | 2 / 24 |
Outcome results
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13
UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.
Time frame: Baseline, Week 13
Population: The Full Analysis Set (FAS) was defined as all enrolled participants who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collection. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13 | -12.283 Percentage change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13 | -0.045 Percentage change |
Change From Baseline in Blood Pressure
Change from baseline in blood pressure and at baseline values were reported for this outcome measure.
Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 13 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 11.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week15 | -7.5 Millimeter of mercury (mmHg) | Standard Deviation 5.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 17 | -7.3 Millimeter of mercury (mmHg) | Standard Deviation 12.7 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 19 | -8.0 Millimeter of mercury (mmHg) | Standard Deviation 8.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 21 | -8.0 Millimeter of mercury (mmHg) | Standard Deviation 16.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 23 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 9 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 25 | -9.0 Millimeter of mercury (mmHg) | Standard Deviation 13.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 27 | -3.0 Millimeter of mercury (mmHg) | Standard Deviation 10.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 29 | -8.3 Millimeter of mercury (mmHg) | Standard Deviation 8.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 33 | -12.0 Millimeter of mercury (mmHg) | Standard Deviation 20.7 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Baseline | 131.2 Millimeter of mercury (mmHg) | Standard Deviation 12.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 2 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 13.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 3 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 10.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 5 | -3.0 Millimeter of mercury (mmHg) | Standard Deviation 10.6 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 7 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 11.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 9 | -5.1 Millimeter of mercury (mmHg) | Standard Deviation 10.7 |
| PF-06730512 1000 mg IV | Change From Baseline in Blood Pressure | Week 11 | -1.5 Millimeter of mercury (mmHg) | Standard Deviation 12.5 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 5 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 9 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 13 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 10 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 33 | 4.6 Millimeter of mercury (mmHg) | Standard Deviation 8.9 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week15 | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 6.2 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 21 | -5.8 Millimeter of mercury (mmHg) | Standard Deviation 10.1 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 17 | -7.7 Millimeter of mercury (mmHg) | Standard Deviation 12.2 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Baseline | 125.3 Millimeter of mercury (mmHg) | Standard Deviation 11.8 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 19 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 10.7 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 7 | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 9 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 2 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 7.8 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 23 | -3.6 Millimeter of mercury (mmHg) | Standard Deviation 8.2 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 11 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 6.1 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 25 | -2.6 Millimeter of mercury (mmHg) | Standard Deviation 11.2 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 3 | 1.7 Millimeter of mercury (mmHg) | Standard Deviation 7.5 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 27 | 3.5 Millimeter of mercury (mmHg) | Standard Deviation 10.5 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 9 | -2.6 Millimeter of mercury (mmHg) | Standard Deviation 7.6 |
| PF-06730512 300 mg IV | Change From Baseline in Blood Pressure | Week 29 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 11.2 |
Change From Baseline in Body Temperature
Change from baseline in body temperature and at baseline values were reported for this outcome measure.
Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 2 | 0.1 Degree Celsius | Standard Deviation 0.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 17 | 0.1 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 9 | 0.0 Degree Celsius | Standard Deviation 0.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 19 | 0.1 Degree Celsius | Standard Deviation 0.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 5 | 0.0 Degree Celsius | Standard Deviation 0.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 21 | -0.0 Degree Celsius | Standard Deviation 0.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 11 | 0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 23 | 0.2 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 3 | 0.0 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 25 | 0.1 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 13 | -0.1 Degree Celsius | Standard Deviation 0.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 27 | 0.1 Degree Celsius | Standard Deviation 0.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 7 | 0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 29 | 0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 15 | 0.2 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Week 33 | 0.1 Degree Celsius | Standard Deviation 0.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Temperature | Baseline | 36.4 Degree Celsius | Standard Deviation 0.4 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 33 | -0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Baseline | 36.6 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 2 | -0.0 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 3 | -0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 5 | -0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 7 | -0.0 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 9 | -0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 11 | -0.0 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 13 | -0.0 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 15 | 0.1 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 17 | 0.1 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 19 | 0.1 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 21 | -0.1 Degree Celsius | Standard Deviation 0.5 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 23 | 0.0 Degree Celsius | Standard Deviation 0.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 25 | 0.0 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 27 | 0.1 Degree Celsius | Standard Deviation 0.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Temperature | Week 29 | -0.1 Degree Celsius | Standard Deviation 0.4 |
Change From Baseline in Body Weight
Change from baseline in body weight and at baseline values were reported for this outcome measure.
Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 27 | 0.7 Kilogram | Standard Deviation 1.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Baseline | 78.3 Kilogram | Standard Deviation 17.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 2 | 1.0 Kilogram | Standard Deviation 2.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 3 | 0.4 Kilogram | Standard Deviation 2.5 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 5 | 0.5 Kilogram | Standard Deviation 3 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 7 | 0.6 Kilogram | Standard Deviation 2.6 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 9 | 0.1 Kilogram | Standard Deviation 3.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 11 | 0.7 Kilogram | Standard Deviation 2.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 13 | -0.2 Kilogram | Standard Deviation 1.9 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week15 | -0.3 Kilogram | Standard Deviation 1 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 17 | -0.2 Kilogram | Standard Deviation 1.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 19 | -0.4 Kilogram | Standard Deviation 1 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 21 | 0.3 Kilogram | Standard Deviation 1.7 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 23 | 0.3 Kilogram | Standard Deviation 1.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 25 | -0.1 Kilogram | Standard Deviation 1.6 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 29 | 0.5 Kilogram | Standard Deviation 1.5 |
| PF-06730512 1000 mg IV | Change From Baseline in Body Weight | Week 33 | 0.5 Kilogram | Standard Deviation 1.6 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 23 | -1.5 Kilogram | Standard Deviation 5.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week15 | -0.7 Kilogram | Standard Deviation 4 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Baseline | 88.9 Kilogram | Standard Deviation 23.5 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 29 | -1.0 Kilogram | Standard Deviation 4.5 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 2 | -0.3 Kilogram | Standard Deviation 1.9 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 17 | -1.2 Kilogram | Standard Deviation 4.8 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 3 | -0.3 Kilogram | Standard Deviation 2.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 25 | -1.1 Kilogram | Standard Deviation 4.8 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 5 | -0.5 Kilogram | Standard Deviation 4.8 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 19 | -1.3 Kilogram | Standard Deviation 4.8 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 7 | -1.0 Kilogram | Standard Deviation 5.3 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 27 | -0.6 Kilogram | Standard Deviation 5.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 9 | -0.4 Kilogram | Standard Deviation 3.4 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 21 | -1.3 Kilogram | Standard Deviation 4.9 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 11 | -0.1 Kilogram | Standard Deviation 4.2 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 33 | -0.6 Kilogram | Standard Deviation 5.4 |
| PF-06730512 300 mg IV | Change From Baseline in Body Weight | Week 13 | -1.0 Kilogram | Standard Deviation 3.4 |
Change From Baseline in Pulse Rate
Change from baseline in pulse rate and at baseline values were reported for this outcome measure.
Time frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 2 | 2.1 Beats per minute | Standard Deviation 9.6 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 17 | -6.3 Beats per minute | Standard Deviation 8.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 9 | -1.0 Beats per minute | Standard Deviation 11.1 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 19 | -3.5 Beats per minute | Standard Deviation 13.7 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 5 | 0.0 Beats per minute | Standard Deviation 7.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 21 | -5.5 Beats per minute | Standard Deviation 12.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 11 | -1.7 Beats per minute | Standard Deviation 10.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 23 | -3.3 Beats per minute | Standard Deviation 10.5 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 3 | -0.6 Beats per minute | Standard Deviation 8 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 25 | -6.3 Beats per minute | Standard Deviation 12.5 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 13 | 3.3 Beats per minute | Standard Deviation 11.9 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 27 | -0.8 Beats per minute | Standard Deviation 16 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 7 | -0.3 Beats per minute | Standard Deviation 9.2 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 29 | 2.5 Beats per minute | Standard Deviation 14.8 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week15 | -5.8 Beats per minute | Standard Deviation 10.4 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Week 33 | -0.5 Beats per minute | Standard Deviation 15.3 |
| PF-06730512 1000 mg IV | Change From Baseline in Pulse Rate | Baseline | 74.1 Beats per minute | Standard Deviation 11.8 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 33 | 6.2 Beats per minute | Standard Deviation 10 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Baseline | 74.2 Beats per minute | Standard Deviation 11 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 2 | 0.6 Beats per minute | Standard Deviation 6.9 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 3 | -1.1 Beats per minute | Standard Deviation 6 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 5 | -0.3 Beats per minute | Standard Deviation 8 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 7 | 0.0 Beats per minute | Standard Deviation 7.9 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 9 | 1.5 Beats per minute | Standard Deviation 9 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 11 | 0.6 Beats per minute | Standard Deviation 6.6 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 13 | 0.5 Beats per minute | Standard Deviation 6.9 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week15 | 5.0 Beats per minute | Standard Deviation 10.1 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 17 | -2.2 Beats per minute | Standard Deviation 5 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 19 | 2.9 Beats per minute | Standard Deviation 6.5 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 21 | -1.6 Beats per minute | Standard Deviation 5 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 23 | -3.1 Beats per minute | Standard Deviation 9 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 25 | 1.8 Beats per minute | Standard Deviation 7.6 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 27 | 2.9 Beats per minute | Standard Deviation 7.2 |
| PF-06730512 300 mg IV | Change From Baseline in Pulse Rate | Week 29 | 5.9 Beats per minute | Standard Deviation 8.8 |
Number of Participants With Abnormalities in Electrocardiogram (ECG)
ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (\>) 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 3) Heart rate (bpm): RR decrease \>25% and to a VR (interval between QRS wave and T wave on ECG) \>100; RR (interval between 2 successive R waves on ECG) increase \>25% and to a VR \<50; 4) Pulse rate (msec): increase \>25% and to a value \>200; 5) QT (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 6) QRS (msec): increase \>25% and to a value \>110. Categories (timepoints) with at least 1 participant having ECG abnormality in any of the reporting arms, were reported for this outcome measure.
Time frame: Weeks 3, 7, 11, 13, 17, 21, 25, 33
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 3 (Not Clinically Significant) | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 3 (Clinically Significant) | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 7 (Not Clinically Significant) | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 7 (Clinically Significant) | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 11 (Not Clinically Significant) | 4 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 11 (Clinically Significant) | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 13 (Not Clinically Significant) | 6 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 13 (Clinically Significant) | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 17 (Not Clinically Significant) | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 17 (Clinically Significant) | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 21 (Not Clinically Significant) | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 21 (Clinically Significant) | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 25 (Not Clinically Significant) | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 25 (Clinically Significant) | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 33 (Not Clinically Significant) | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 33 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 33 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 3 (Not Clinically Significant) | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 17 (Not Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 3 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 25 (Not Clinically Significant) | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 7 (Not Clinically Significant) | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 17 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 7 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 33 (Not Clinically Significant) | 2 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 11 (Not Clinically Significant) | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 21 (Not Clinically Significant) | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 11 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 25 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 13 (Not Clinically Significant) | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 21 (Clinically Significant) | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Electrocardiogram (ECG) | Week 13 (Clinically Significant) | 0 Participants |
Number of Participants With Abnormalities in Laboratory Test Parameters
Hemoglobin (Hg), hematocrit, erythrocytes: \<0.8\*lower limits of normal (LLN); platelets: \<0.5\*LLN\>1.75\*upper limits of normal(ULN); leukocytes (leu), glucose-fasting:\<0.6\*LLN\>1.5\*ULN; lymphocytes (lym), lym/leu, neutrophils(neu),neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: \<0.8\*LLN\>1.2\*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: \>1.2\*ULN; bilirubin (total, direct, indirect):\>1.5\*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol (total,LDL,HDL),triglycerides, Hg A1C: \>1.3\*ULN; sodium: \<0.95\*LLN\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLLN\>1.1\*ULN; prolactin: \>1.1\*ULN; creatine kinase: \>2.0\*ULN; urobilinogen: \>=1; Urine-specific gravity: \<1.003\>1.030, pH: \<4.5 \>8, glucose,protein,bilirubin,nitrite,leukocyte esterase, ketones: \>=1.Categories with at-least 1 non-zero values are reported.
Time frame: From Day 1 of treatment up to Week 33
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Hemoglobin < 0.8 * Lower Limit Number (LLN) | 5 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Hematocrit < 0.8 * LLN | 5 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Ery. Mean Corpuscular Volume < 0.9 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Ery. Mean Corpuscular Hemoglobin < 0.9 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Erythrocytes < 0.8 * LLN | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Platelets> 1.75 * ULN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Lymphocytes< 0.8 * LLN | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Lymphocytes/Leukocytes < 0.8 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Lymphocytes/Leukocytes > 1.2 * ULN | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils < 0.8 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils > 1.2 * ULN | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils/Leukocytes < 0.8 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils/Leukocytes > 1.2 * ULN | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Eosinophils > 1.2 * ULN | 2 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Eosinophils/Leukocytes> 1.2 * ULN | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Monocytes/Leukocytes> 1.2 * ULN | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Aspartate Aminotransferase > 3.0 * ULN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Alanine Aminotransferase > 3.0 * ULN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Protein < 0.8 * LLN | 9 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Albumin < 0.8 * LLN | 8 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Blood Urea Nitrogen > 1.3 * ULN | 10 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Creatinine > 1.3 * ULN | 8 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Urate > 1.2 * ULN | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Cholesterol > 1.3 * ULN | 6 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: HDL Cholesterol < 0.8 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: LDL Cholesterol > 1.2 * ULN | 6 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Triglycerides > 1.3 * ULN | 6 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Sodium < 0.95 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Potassium < 0.9 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Potassium > 1.1 * ULN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Calcium < 0.9 * LLN | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Bicarbonate < 0.9 * LLN | 0 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Glucose > 1.5 * ULN | 2 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Specific Gravity > 1.030 | 5 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: pH > 8 | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Glucose >= 1 | 5 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Protein >=1 | 22 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Hemoglobin >=1 | 15 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Nitrite >= 1 | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Leukocyte Esterase >= 1 | 5 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Erythrocytes >= 20 | 3 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Leukocytes >= 20 | 2 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Granular Casts > 1 | 4 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Hyaline Casts > 1 | 17 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Creatinine <40 | 9 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Creatinine >300 | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine (24HR) Creatinine > 1.1 * ULN | 2 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Cholesterol > 1.3 * ULN | 7 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Hemoglobin < 0.8 * Lower Limit Number (LLN) | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Glucose >= 1 | 10 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Hematocrit < 0.8 * LLN | 7 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Erythrocytes < 0.8 * LLN | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: HDL Cholesterol < 0.8 * LLN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Ery. Mean Corpuscular Volume < 0.9 * LLN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Leukocytes >= 20 | 5 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Ery. Mean Corpuscular Hemoglobin < 0.9 * LLN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: LDL Cholesterol > 1.2 * ULN | 5 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Protein >=1 | 24 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Platelets> 1.75 * ULN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Triglycerides > 1.3 * ULN | 8 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Lymphocytes< 0.8 * LLN | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Creatinine <40 | 8 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Lymphocytes/Leukocytes < 0.8 * LLN | 6 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Sodium < 0.95 * LLN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Lymphocytes/Leukocytes > 1.2 * ULN | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Hemoglobin >=1 | 17 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils < 0.8 * LLN | 2 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Potassium < 0.9 * LLN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils > 1.2 * ULN | 4 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Granular Casts > 1 | 2 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils/Leukocytes < 0.8 * LLN | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Potassium > 1.1 * ULN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Neutrophils/Leukocytes > 1.2 * ULN | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Nitrite >= 1 | 3 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Eosinophils > 1.2 * ULN | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Calcium < 0.9 * LLN | 3 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Eosinophils/Leukocytes> 1.2 * ULN | 3 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine (24HR) Creatinine > 1.1 * ULN | 6 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Hematology: Monocytes/Leukocytes> 1.2 * ULN | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Bicarbonate < 0.9 * LLN | 1 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Aspartate Aminotransferase > 3.0 * ULN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Leukocyte Esterase >= 1 | 6 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Alanine Aminotransferase > 3.0 * ULN | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Glucose > 1.5 * ULN | 2 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Protein < 0.8 * LLN | 11 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Hyaline Casts > 1 | 15 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Albumin < 0.8 * LLN | 11 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Specific Gravity > 1.030 | 6 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Blood Urea Nitrogen > 1.3 * ULN | 8 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Erythrocytes >= 20 | 3 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Creatinine > 1.3 * ULN | 12 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: pH > 8 | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Clinical chemistry: Urate > 1.2 * ULN | 2 Participants |
| PF-06730512 300 mg IV | Number of Participants With Abnormalities in Laboratory Test Parameters | Urinalysis: Urine Creatinine >300 | 0 Participants |
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)
Number of participants with positive ADA and/or NAb were reported for this outcome measure.
Time frame: From Day 1 of treatment up to Week 33
Population: The immunogenicity analysis population included all treated participants with at least 1 ADA sample (pre-dose or post-treatment) analyzed. Participants those had only pre-dose baseline data and no post-treatment immunogenicity data, was not evaluated for subject-level ADA and NAb status. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06730512 1000 mg IV | Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) | ADA Positive | 1 Participants |
| PF-06730512 1000 mg IV | Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) | nAb Positive | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) | ADA Positive | 0 Participants |
| PF-06730512 300 mg IV | Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) | nAb Positive | 0 Participants |
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event was considered treatment emergent relative to a given treatment if the event occurred for the first time during the investigational treatment period and was not seen prior to the start of treatment (during the lead-in period), or the event was seen prior to the start of treatment but increased in severity during treatment. Adverse events occurring during the lead-in period were considered non-treatment emergent. Events that occurred during the follow-Up period were counted as treatment emergent and attributed to the previous treatment taken.
Time frame: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)
Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06730512 1000 mg IV | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 20 Participants |
| PF-06730512 300 mg IV | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 17 Participants |
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13
The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration, age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) = 175\*(sCr/88.4)\^-1.154\*(Age)\^-0.203\*(0.742 if female)\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). For Baseline eGFR, the Low eGFR group was defined as baseline eGFR \< 45 mL/min/1.73m2, and the High eGFR group was defined as baseline eGFR \> 45 mL/min/1.73 m2.
Time frame: Baseline, Weeks 3, 5, 9 and 13
Population: FAS was defined as all enrolled subjects who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collected. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 3 | 5.657 Percent change |
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 5 | 2.174 Percent change |
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 9 | -1.536 Percent change |
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 13 | 2.892 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 13 | -12.217 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 3 | -0.180 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 9 | -5.017 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 | Week 5 | -2.038 Percent change |
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13
UPCR is a ratio between two measured substances in urine: mmol of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.
Time frame: Baseline, Weeks 2, 5, 9 and 13
Population: FAS was defined as all enrolled subjects who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collected. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 13 | -12.283 Percent change |
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 9 | -11.335 Percent change |
| PF-06730512 1000 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 5 | 6.250 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 5 | -3.788 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 13 | -0.045 Percent change |
| PF-06730512 300 mg IV | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 9 | -2.354 Percent change |
| Unknown | Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 | Week 2 | — Percent change |
Serum PF-06730512 Concentration Versus Time Summary
Time frame: For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT)
Population: The PK concentration analysis set was defined as all enrolled participants treated who received at least one dose of PF-06730512 and had at least 1 measurable concentration. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 141: Pre-dose (24WT) | 38.00 Microgram per milliliter | Standard Deviation 13.88 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 1: Post-dose (12,24WT) | 279.4 Microgram per milliliter | Standard Deviation 86.548 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 8: Pre-dose (12,24WT) | 39.50 Microgram per milliliter | — |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 15: Pre-dose (12,24WT) | 16.45 Microgram per milliliter | Standard Deviation 11.266 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 29: Pre-dose (12,24WT) | 24.92 Microgram per milliliter | Standard Deviation 20.256 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 43: Pre-dose (12,24WT) | 29.96 Microgram per milliliter | Standard Deviation 22.062 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 57: Pre-dose (12,24WT) | 32.56 Microgram per milliliter | Standard Deviation 23.031 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 71: Pre-dose (12,24WT) | 27.32 Microgram per milliliter | Standard Deviation 16.688 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 71: Post-dose(12,24WT) | 298.6 Microgram per milliliter | Standard Deviation 208.87 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 85: Pre-dose (24WT) | 41.15 Microgram per milliliter | Standard Deviation 23.516 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 85/Fup (12 WT) | 27.19 Microgram per milliliter | Standard Deviation 21.589 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 99/Fup (12 WT) | 11.50 Microgram per milliliter | Standard Deviation 12.948 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 113/Fup (12 WT) | 4.991 Microgram per milliliter | Standard Deviation 6.1121 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 141/Fup (12 WT) | 1.385 Microgram per milliliter | Standard Deviation 2.1196 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 99: Pre-dose (24WT) | 35.65 Microgram per milliliter | Standard Deviation 16.065 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 113: Pre-dose (24WT) | 42.40 Microgram per milliliter | Standard Deviation 25.049 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 127: Pre-dose (24WT) | 30.67 Microgram per milliliter | Standard Deviation 5.3463 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 1: Pre-dose (12,24WT) | 0 Microgram per milliliter | Standard Deviation 0 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 155: Post-dose (24WT) | 313.3 Microgram per milliliter | Standard Deviation 63.793 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 169: Pre-dose/Fup (24WT) | 29.32 Microgram per milliliter | Standard Deviation 15.338 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 183/Fup (24WT) | 25.79 Microgram per milliliter | Standard Deviation 30.417 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 197/Fup (24WT) | 6.108 Microgram per milliliter | Standard Deviation 4.0049 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 225/Fup (24WT) | 2.009 Microgram per milliliter | Standard Deviation 1.6808 |
| PF-06730512 1000 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 155: Pre-dose (24WT) | 32.57 Microgram per milliliter | Standard Deviation 5.8287 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 141: Pre-dose (24WT) | 8.957 Microgram per milliliter | Standard Deviation 10.753 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 1: Pre-dose (12,24WT) | 0 Microgram per milliliter | Standard Deviation 0 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 113/Fup (12 WT) | 0.6356 Microgram per milliliter | Standard Deviation 0.81118 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 1: Post-dose (12,24WT) | 71.94 Microgram per milliliter | Standard Deviation 29.668 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 197/Fup (24WT) | 1.048 Microgram per milliliter | Standard Deviation 1.4978 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 8: Pre-dose (12,24WT) | 13.09 Microgram per milliliter | Standard Deviation 6.9363 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 155: Pre-dose (24WT) | 7.585 Microgram per milliliter | Standard Deviation 8.1601 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 15: Pre-dose (12,24WT) | 5.096 Microgram per milliliter | Standard Deviation 3.1184 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 141/Fup (12 WT) | 0.1438 Microgram per milliliter | Standard Deviation 0.21666 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 29: Pre-dose (12,24WT) | 6.916 Microgram per milliliter | Standard Deviation 5.0154 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 225/Fup (24WT) | 0.2659 Microgram per milliliter | Standard Deviation 0.45714 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 43: Pre-dose (12,24WT) | 6.991 Microgram per milliliter | Standard Deviation 5.5862 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 99: Pre-dose (24WT) | 7.084 Microgram per milliliter | Standard Deviation 6.9224 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 57: Pre-dose (12,24WT) | 7.664 Microgram per milliliter | Standard Deviation 6.1325 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 155: Post-dose (24WT) | 62.71 Microgram per milliliter | Standard Deviation 41.324 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 71: Pre-dose (12,24WT) | 6.736 Microgram per milliliter | Standard Deviation 5.6237 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 113: Pre-dose (24WT) | 9.442 Microgram per milliliter | Standard Deviation 8.6965 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 71: Post-dose(12,24WT) | 129.2 Microgram per milliliter | Standard Deviation 201.5 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 183/Fup (24WT) | 3.046 Microgram per milliliter | Standard Deviation 3.8895 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 85: Pre-dose (24WT) | 7.597 Microgram per milliliter | Standard Deviation 6.9184 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 127: Pre-dose (24WT) | 6.732 Microgram per milliliter | Standard Deviation 5.2295 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 85/Fup (12 WT) | 6.884 Microgram per milliliter | Standard Deviation 7.1511 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 169: Pre-dose/Fup (24WT) | 7.989 Microgram per milliliter | Standard Deviation 7.474 |
| PF-06730512 300 mg IV | Serum PF-06730512 Concentration Versus Time Summary | Day 99/Fup (12 WT) | 2.313 Microgram per milliliter | Standard Deviation 3.1827 |