Healthy, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Primary Immune Thrombocytopenia
Conditions
Brief summary
This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP). Pharmacokinetics and pharmacodynamics will also be evaluated.
Interventions
DRUGPF-06755347 intravenous healthy participant
Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
DRUGPlacebo intravenous healthy participant
Placebo comparator
DRUGPF-06755347 subcutaneous healthy participant
single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
DRUGPlacebo subcutaneous healthy participant
placebo comparator
DRUGPF-06755347 subcutaneous ITP
single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind (investigator and subject), sponsor open in healthy male participants. Masking will not be applied for participants with ITP (all ITP participants will receive PF-06755347).
Intervention model description
single ascending dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male participants: * at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, blood pressure (BP) and pulse rate measurement, pulse oximetry, 12 lead ECG or clinical laboratory tests. * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * Chest X ray with no evidence of current, active tuberculosis (TB) or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Screening and read by a qualified radiologist.
Exclusion criteria
for Healthy male participants: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Participants with a history of autoimmune disorders and other conditions that compromise or impair the immune system (including but not limited to: Crohns Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves disease, and asthma) or have a current positive result for the following; rheumatoid factor, anti-nuclear antibody, or abnormal free triiodothyronine (T3), free thyroxine (T4), thyroid stimulating hormone (TSH), or thyroid stimulating antibody (TSAb) suggestive of thyroid disease. * Subjects with a history of allergic or anaphylactic reaction to any drug including immunoglobulin. * History of active infections within 28 days prior to the screening visit. * Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HepBsAg), Hepatitis B core antibody (HepBcAb), Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV). * Subjects with a history of thromboembolic events. * History of TB or active, latent or inadequately treated TB infection. All positive TB test result(s) are exclusionary * Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study. * Inclusion Criteria for ITP participants: Female participants may be of childbearing potential or non-childbearing potential. -Diagnosis of Primary ITP. ITP must be diagnosed in accordance with established guidelines. ITP duration-Persistent (\>3 months and ≤12 months) OR Chronic (\>12 months). AND * Platelet count 30-75 x 10E9/L (inclusive) with criteria achieved on 2 qualifying counts at least 5 days apart and within approx. 10 days of dosing * Participants must have received and responded to IVIg or corticosteroids as treatment for ITP (response is defined as achievement of platelet count \>50 x 109/L and doubling of platelet count from baseline). --Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * BMI of 17.5 to 30.5 kg/m2 and a total body weight \>40 kg (88 lbs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts). | Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs. |
| Number of Participants With Laboratory Test Abnormalities | Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts. | Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported. |
| Number of Participants With Vital Signs Meeting Categorical Criteria | Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts. | Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1. |
| Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts). | Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to \<480 msec; QTcF interval ≥480 to \<500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline \>200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: \>30 to ≤60 msec; QTcF interval change from baseline \>60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence. |
| Tmax of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence. |
| Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | AUClast was determined using linear/Log trapezoidal method |
| AUClast of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | AUClast was determined using linear/Log trapezoidal method |
| Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | AUClast(dn) = AUClast/Dose |
| AUClast(dn) of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | AUClast(dn) = AUClast/Dose |
| Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| AUCinf of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | AUCinf(dn) = AUCinf/Dose |
| AUCinf(dn) of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | AUCinf(dn) = AUCinf/Dose |
| Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | Cmax was the highest concentration observed directly from data |
| t½ of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Clearance (CL) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug. |
| Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. |
| Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts | Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1. |
| Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. | IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. |
| Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. | TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. |
| Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. | IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. |
| Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. | C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. |
| Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. | C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. |
| Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts. | Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1. |
| Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Cmax of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | Cmax was the highest concentration observed directly from data |
| Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6. | Cmax(dn) = Cmax/Dose |
| Cmax(dn) of PF-06755347 Following Single SC Dose | Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71. | Cmax(dn) = Cmax/Dose |
Countries
Belgium, New Zealand, Spain, United Kingdom, United States
Participant flow
Recruitment details
The study planned 14 cohorts, however, it was terminated due to non-safety reasons during Cohort 11, with no further enrollment. Included in this study were all healthy participants, who were randomized to either receive PF-06755347 or placebo by intravenous (IV) or subcutaneous (SC) administration in a 3:1 allocation ratio. A total of 58 participants were dosed in this study: 42 received PF-06755347 and 16 received placebo.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV Healthy participants received single dose of PF-06755347 0.01 mg/kg IV on Day 1. | 3 |
| Cohort 2: PF-06755347 0.03 mg/kg IV Healthy participants received single dose of PF-06755347 0.03 mg/kg IV on Day 1. | 3 |
| Cohort 3: PF-06755347 0.1 mg/kg IV Healthy participants received single dose of PF-06755347 0.1 mg/kg IV on Day 1. | 3 |
| Cohort 4: PF-06755347 0.3 mg/kg IV Healthy participants received single dose of PF-06755347 0.3 mg/kg IV on Day 1. | 3 |
| Cohort 5: PF-06755347 1 mg/kg IV Healthy participants received single dose of PF-06755347 1 mg/kg IV on Day 1. | 3 |
| Cohort 6: PF-06755347 0.7 mg/kg IV Healthy participants received single dose of PF-06755347 0.7 mg/kg IV on Day 1. | 3 |
| Cohort 7: PF-06755347 25 mg SC Healthy participants received single dose of PF-06755347 25 mg SC on Day 1. | 3 |
| Cohort 8: PF-06755347 50 mg SC Healthy participants received single dose of PF-06755347 50 mg SC on Day 1. | 6 |
| Cohort 9: PF-06755347 100 mg SC Healthy participants received single dose of PF-06755347 100 mg SC on Day 1. | 6 |
| Cohort 10: PF-06755347 200 mg SC Healthy participants received single dose of PF-06755347 200 mg SC on Day 1. | 6 |
| Cohort 11: PF-06755347 300 mg SC Healthy participants received single dose of PF-06755347 300 mg SC on Day 1. | 3 |
| Placebo Healthy participants received single dose of placebo matching PF-06755347 IV or SC cohorts on Day 1. | 16 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | due to coronaviras disease 2019 (COVID-19) pandemic | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-25 years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants | 15 Participants |
| Age, Customized 26-35 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 5 Participants | 17 Participants |
| Age, Customized 36-45 years | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 14 Participants |
| Age, Customized 46-55 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 3 Participants | 14 Participants | 52 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 5 Participants | 6 Participants | 4 Participants | 3 Participants | 16 Participants | 54 Participants |
| Sex: Female, Male Female | 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 |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 16 Participants | 58 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 16 |
| other Total, other adverse events | 3 / 3 | 2 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 2 / 3 | 3 / 3 | 6 / 6 | 6 / 6 | 5 / 6 | 3 / 3 | 10 / 16 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 1 / 3 | 0 / 3 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 16 |
Outcome results
Primary
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
Time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
Population: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 2 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 2 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 2 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 2 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 2 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 3 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 3 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 1 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 2 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 5 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 6 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 6 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 6 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 4 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 5 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 3 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 3 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Placebo | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Discontinuations from study due to TEAEs | 0 Participants |
| Placebo | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Treatment-related TEAEs | 7 Participants |
| Placebo | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | Serious TEAEs | 0 Participants |
| Placebo | Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs | All-causality TEAEs | 10 Participants |
Primary
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to \<480 msec; QTcF interval ≥480 to \<500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline \>200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: \>30 to ≤60 msec; QTcF interval change from baseline \>60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1.
Time frame: Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts).
Population: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥450 to <480 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration: percent change from baseline ≥50% | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QRS duration ≥140 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval: percent change from baseline ≥25/50% | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >60 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval change from baseline: >30 msec to ≤60 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval: ≥480 to <500 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | PR interval ≥300 msec | 0 Participants |
| Placebo | Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria | QTcF interval ≥500 msec | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
Time frame: Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.
Population: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 1 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 1 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 1 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 2 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 1 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 1 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 2 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 2 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 1 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 3 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 1 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 2 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 2 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 2 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 2 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 2 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 3 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 2 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 1 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 1 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 1 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 1 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 2 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 2 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 2 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 3 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 2 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 2 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 2 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 3 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 2 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 2 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | pH >8 | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 2 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 1 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Neutrophils <0.8 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Creatine Kinase >2.0 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Specific Gravity >1.030 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Specific Gravity <1.003 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Ketones ≥1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Bicarbonate >1.1 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Lymphocytes/ Leukocytes >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Direct Bilirubin >1.5 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Monocytes >1.2 x ULN | 2 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Leukocytes <0.6 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Bilirubin >1.5 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 3 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Aspartate Aminotransferase >3.0 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | pH >8 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Neutrophils >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Monocytes/Leukocytes >1.2 x ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Eosinophils >1.2 x ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Eosinophils/Leukocytes >1.2 x ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Urea >1.3 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | URINE Bilirubin ≥1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Fibrinogen >1.25 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | D-Dimer >1.5 x ULN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Leukocyte Esterase ≥1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Urobilinogen ≥1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | URINE Hemoglobin ≥1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Nitrite ≥1 | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Urate >1.2 x ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | Lymphocytes <0.8 x LLN | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | URINE Protein ≥1 | 1 Participants |
| Placebo | Number of Participants With Laboratory Test Abnormalities | C Reactive Protein >1.1 x ULN | 0 Participants |
Primary
Number of Participants With Vital Signs Meeting Categorical Criteria
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1.
Time frame: Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.
Population: All participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 1 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 2 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 1 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 6 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 3 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 1 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 5 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 3 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 1 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: decrease from baseline ≥20 mmHg | 0 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate >120 bpm | 0 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP: increase from baseline ≥20 mmHg | 0 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | Pulse rate <40 bpm | 0 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP <90 mmHg | 0 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: increase from baseline ≥30 mmHg | 0 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | DBP <50 mmHg | 1 Participants |
| Placebo | Number of Participants With Vital Signs Meeting Categorical Criteria | SBP: decrease from baseline ≥30 mmHg | 0 Participants |
Secondary
Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose
CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | 0.1876 L/hr | Geometric Coefficient of Variation 11 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | 0.2128 L/hr | Geometric Coefficient of Variation 42 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | 0.2272 L/hr | Geometric Coefficient of Variation 25 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | 0.2321 L/hr | Geometric Coefficient of Variation 15 |
| Cohort 5: PF-06755347 1 mg/kg IV | Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | 0.3036 L/hr | Geometric Coefficient of Variation 30 |
Secondary
Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: PF-06755347 0.03 mg/kg IV | Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | 12.52 ug*hr/mL | Geometric Coefficient of Variation 25 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | 49.35 ug*hr/mL | Geometric Coefficient of Variation 10 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | 162.7 ug*hr/mL | Geometric Coefficient of Variation 8 |
| Cohort 5: PF-06755347 1 mg/kg IV | Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | 569.7 ug*hr/mL | Geometric Coefficient of Variation 29 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | NA ug*hr/mL | — |
Secondary
Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose
AUClast was determined using linear/Log trapezoidal method
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 1.395 micrograms*hour/milliliter (ug*hr/mL) | Geometric Coefficient of Variation 70 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 10.51 micrograms*hour/milliliter (ug*hr/mL) | Geometric Coefficient of Variation 30 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 45.18 micrograms*hour/milliliter (ug*hr/mL) | Geometric Coefficient of Variation 9 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 156.4 micrograms*hour/milliliter (ug*hr/mL) | Geometric Coefficient of Variation 7 |
| Cohort 5: PF-06755347 1 mg/kg IV | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 511.8 micrograms*hour/milliliter (ug*hr/mL) | Geometric Coefficient of Variation 29 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 316.2 micrograms*hour/milliliter (ug*hr/mL) | Geometric Coefficient of Variation 3 |
Secondary
AUCinf(dn) of PF-06755347 Following Single SC Dose
AUCinf(dn) = AUCinf/Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | AUCinf(dn) of PF-06755347 Following Single SC Dose | 5.323 ug*hr/mL/mg | Geometric Coefficient of Variation 11 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | AUCinf(dn) of PF-06755347 Following Single SC Dose | 4.695 ug*hr/mL/mg | Geometric Coefficient of Variation 42 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | AUCinf(dn) of PF-06755347 Following Single SC Dose | 4.401 ug*hr/mL/mg | Geometric Coefficient of Variation 25 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | AUCinf(dn) of PF-06755347 Following Single SC Dose | 4.305 ug*hr/mL/mg | Geometric Coefficient of Variation 15 |
| Cohort 5: PF-06755347 1 mg/kg IV | AUCinf(dn) of PF-06755347 Following Single SC Dose | 3.295 ug*hr/mL/mg | Geometric Coefficient of Variation 30 |
Secondary
AUCinf of PF-06755347 Following Single SC Dose
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | AUCinf of PF-06755347 Following Single SC Dose | 133.2 ug*hr/mL | Geometric Coefficient of Variation 10 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | AUCinf of PF-06755347 Following Single SC Dose | 234.7 ug*hr/mL | Geometric Coefficient of Variation 42 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | AUCinf of PF-06755347 Following Single SC Dose | 440.1 ug*hr/mL | Geometric Coefficient of Variation 25 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | AUCinf of PF-06755347 Following Single SC Dose | 861.3 ug*hr/mL | Geometric Coefficient of Variation 15 |
| Cohort 5: PF-06755347 1 mg/kg IV | AUCinf of PF-06755347 Following Single SC Dose | 988.8 ug*hr/mL | Geometric Coefficient of Variation 30 |
Secondary
AUClast(dn) of PF-06755347 Following Single SC Dose
AUClast(dn) = AUClast/Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | AUClast(dn) of PF-06755347 Following Single SC Dose | 5.010 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 13 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | AUClast(dn) of PF-06755347 Following Single SC Dose | 4.603 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 42 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | AUClast(dn) of PF-06755347 Following Single SC Dose | 4.287 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 24 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | AUClast(dn) of PF-06755347 Following Single SC Dose | 4.297 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 13 |
| Cohort 5: PF-06755347 1 mg/kg IV | AUClast(dn) of PF-06755347 Following Single SC Dose | 3.263 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 30 |
Secondary
AUClast of PF-06755347 Following Single SC Dose
AUClast was determined using linear/Log trapezoidal method
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | AUClast of PF-06755347 Following Single SC Dose | 125.4 ug*hr/mL | Geometric Coefficient of Variation 12 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | AUClast of PF-06755347 Following Single SC Dose | 230.2 ug*hr/mL | Geometric Coefficient of Variation 42 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | AUClast of PF-06755347 Following Single SC Dose | 428.7 ug*hr/mL | Geometric Coefficient of Variation 24 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | AUClast of PF-06755347 Following Single SC Dose | 859.5 ug*hr/mL | Geometric Coefficient of Variation 13 |
| Cohort 5: PF-06755347 1 mg/kg IV | AUClast of PF-06755347 Following Single SC Dose | 977.6 ug*hr/mL | Geometric Coefficient of Variation 30 |
Secondary
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. Number Analyzed in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.360 milligrams per liter (mg/L) | Standard Deviation 0.1637 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.250 milligrams per liter (mg/L) | Standard Deviation 0.2951 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.057 milligrams per liter (mg/L) | Standard Deviation 0.3636 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.277 milligrams per liter (mg/L) | Standard Deviation 0.2574 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.117 milligrams per liter (mg/L) | Standard Deviation 0.398 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.020 milligrams per liter (mg/L) | Standard Deviation 0.5429 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.423 milligrams per liter (mg/L) | Standard Deviation 0.0961 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.133 milligrams per liter (mg/L) | Standard Deviation 0.3057 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.273 milligrams per liter (mg/L) | Standard Deviation 0.0802 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.387 milligrams per liter (mg/L) | Standard Deviation 0.4382 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.100 milligrams per liter (mg/L) | Standard Deviation 0.4911 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.253 milligrams per liter (mg/L) | Standard Deviation 0.0473 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.243 milligrams per liter (mg/L) | Standard Deviation 0.3557 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.217 milligrams per liter (mg/L) | Standard Deviation 0.3121 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.097 milligrams per liter (mg/L) | Standard Deviation 0.3465 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.177 milligrams per liter (mg/L) | Standard Deviation 0.1106 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.230 milligrams per liter (mg/L) | Standard Deviation 0.3974 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.437 milligrams per liter (mg/L) | Standard Deviation 0.2318 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.127 milligrams per liter (mg/L) | Standard Deviation 0.2194 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.233 milligrams per liter (mg/L) | Standard Deviation 0.4041 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.157 milligrams per liter (mg/L) | Standard Deviation 0.2714 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.107 milligrams per liter (mg/L) | Standard Deviation 0.3235 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.117 milligrams per liter (mg/L) | Standard Deviation 0.115 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.680 milligrams per liter (mg/L) | Standard Deviation 0.1735 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.067 milligrams per liter (mg/L) | Standard Deviation 0.1155 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.023 milligrams per liter (mg/L) | Standard Deviation 0.0252 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.593 milligrams per liter (mg/L) | Standard Deviation 0.1943 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.700 milligrams per liter (mg/L) | Standard Deviation 1.0522 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.657 milligrams per liter (mg/L) | Standard Deviation 1.0185 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 1.897 milligrams per liter (mg/L) | Standard Deviation 1.4677 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.577 milligrams per liter (mg/L) | Standard Deviation 1.0866 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.820 milligrams per liter (mg/L) | Standard Deviation 1.3516 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.260 milligrams per liter (mg/L) | Standard Deviation 0.2762 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.977 milligrams per liter (mg/L) | Standard Deviation 0.9903 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.640 milligrams per liter (mg/L) | Standard Deviation 1.1521 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.617 milligrams per liter (mg/L) | Standard Deviation 1.1825 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.110 milligrams per liter (mg/L) | Standard Deviation 0.3772 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 3.713 milligrams per liter (mg/L) | Standard Deviation 1.2371 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 3.920 milligrams per liter (mg/L) | Standard Deviation 1.6404 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.280 milligrams per liter (mg/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.257 milligrams per liter (mg/L) | Standard Deviation 0.4532 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 2.313 milligrams per liter (mg/L) | Standard Deviation 2.3526 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.830 milligrams per liter (mg/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 8 hours post-dose | 1.670 milligrams per liter (mg/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.153 milligrams per liter (mg/L) | Standard Deviation 0.8702 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.377 milligrams per liter (mg/L) | Standard Deviation 0.568 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 2.850 milligrams per liter (mg/L) | Standard Deviation 0.1838 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 4.130 milligrams per liter (mg/L) | Standard Deviation 0.4888 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1.355 milligrams per liter (mg/L) | Standard Deviation 0.0636 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.375 milligrams per liter (mg/L) | Standard Deviation 0.3889 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.145 milligrams per liter (mg/L) | Standard Deviation 0.2051 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.315 milligrams per liter (mg/L) | Standard Deviation 0.4455 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.320 milligrams per liter (mg/L) | Standard Deviation 0.5632 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.100 milligrams per liter (mg/L) | Standard Deviation 0.3219 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.083 milligrams per liter (mg/L) | Standard Deviation 0.294 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.025 milligrams per liter (mg/L) | Standard Deviation 0.0354 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.360 milligrams per liter (mg/L) | Standard Deviation 0.4525 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.090 milligrams per liter (mg/L) | Standard Deviation 0.0707 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.163 milligrams per liter (mg/L) | Standard Deviation 0.1626 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.050 milligrams per liter (mg/L) | Standard Deviation 0.2787 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.127 milligrams per liter (mg/L) | Standard Deviation 0.6966 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.030 milligrams per liter (mg/L) | Standard Deviation 0.5565 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.450 milligrams per liter (mg/L) | Standard Deviation 0.9617 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.073 milligrams per liter (mg/L) | Standard Deviation 0.1563 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.097 milligrams per liter (mg/L) | Standard Deviation 0.5154 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 2.067 milligrams per liter (mg/L) | Standard Deviation 2.8386 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.067 milligrams per liter (mg/L) | Standard Deviation 0.3308 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.100 milligrams per liter (mg/L) | Standard Deviation 0.326 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.117 milligrams per liter (mg/L) | Standard Deviation 0.2011 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.322 milligrams per liter (mg/L) | Standard Deviation 1.614 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -1.165 milligrams per liter (mg/L) | Standard Deviation 2.2748 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.015 milligrams per liter (mg/L) | Standard Deviation 0.7729 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.377 milligrams per liter (mg/L) | Standard Deviation 1.463 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.047 milligrams per liter (mg/L) | Standard Deviation 0.7904 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.518 milligrams per liter (mg/L) | Standard Deviation 1.1527 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.253 milligrams per liter (mg/L) | Standard Deviation 1.4442 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.082 milligrams per liter (mg/L) | Standard Deviation 0.4979 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.090 milligrams per liter (mg/L) | Standard Deviation 1.5773 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 8 hours post-dose | -0.432 milligrams per liter (mg/L) | Standard Deviation 1.5607 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | -1.018 milligrams per liter (mg/L) | Standard Deviation 1.6763 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.318 milligrams per liter (mg/L) | Standard Deviation 1.8083 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.120 milligrams per liter (mg/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.198 milligrams per liter (mg/L) | Standard Deviation 0.1277 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.255 milligrams per liter (mg/L) | Standard Deviation 0.2673 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.240 milligrams per liter (mg/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.818 milligrams per liter (mg/L) | Standard Deviation 0.5851 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.335 milligrams per liter (mg/L) | Standard Deviation 0.2649 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.372 milligrams per liter (mg/L) | Standard Deviation 0.4206 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.048 milligrams per liter (mg/L) | Standard Deviation 0.056 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.158 milligrams per liter (mg/L) | Standard Deviation 0.3306 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.126 milligrams per liter (mg/L) | Standard Deviation 0.2881 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.000 milligrams per liter (mg/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.890 milligrams per liter (mg/L) | Standard Deviation 1.0579 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.220 milligrams per liter (mg/L) | Standard Deviation 0.2082 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -0.466 milligrams per liter (mg/L) | Standard Deviation 0.4039 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.040 milligrams per liter (mg/L) | Standard Deviation 0.2539 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.312 milligrams per liter (mg/L) | Standard Deviation 0.5293 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.445 milligrams per liter (mg/L) | Standard Deviation 0.6457 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.250 milligrams per liter (mg/L) | Standard Deviation 0.3824 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.522 milligrams per liter (mg/L) | Standard Deviation 0.522 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.016 milligrams per liter (mg/L) | Standard Deviation 0.5003 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1.013 milligrams per liter (mg/L) | Standard Deviation 0.8021 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.775 milligrams per liter (mg/L) | Standard Deviation 0.5881 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.908 milligrams per liter (mg/L) | Standard Deviation 1.2157 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.193 milligrams per liter (mg/L) | Standard Deviation 0.3349 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.203 milligrams per liter (mg/L) | Standard Deviation 0.205 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.163 milligrams per liter (mg/L) | Standard Deviation 0.2329 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.673 milligrams per liter (mg/L) | Standard Deviation 0.5974 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.057 milligrams per liter (mg/L) | Standard Deviation 0.0981 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.523 milligrams per liter (mg/L) | Standard Deviation 0.5636 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.583 milligrams per liter (mg/L) | Standard Deviation 1.0104 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.413 milligrams per liter (mg/L) | Standard Deviation 0.3602 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.053 milligrams per liter (mg/L) | Standard Deviation 0.0462 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.160 milligrams per liter (mg/L) | Standard Deviation 0.16 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.018 milligrams per liter (mg/L) | Standard Deviation 0.7665 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.187 milligrams per liter (mg/L) | Standard Deviation 0.5747 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.175 milligrams per liter (mg/L) | Standard Deviation 0.3925 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.016 milligrams per liter (mg/L) | Standard Deviation 0.4309 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.196 milligrams per liter (mg/L) | Standard Deviation 0.592 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.015 milligrams per liter (mg/L) | Standard Deviation 0.2355 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.137 milligrams per liter (mg/L) | Standard Deviation 0.4811 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.132 milligrams per liter (mg/L) | Standard Deviation 0.2589 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.030 milligrams per liter (mg/L) | Standard Deviation 0.2307 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.156 milligrams per liter (mg/L) | Standard Deviation 0.7536 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.058 milligrams per liter (mg/L) | Standard Deviation 0.5159 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.266 milligrams per liter (mg/L) | Standard Deviation 0.496 |
| Placebo | Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.031 milligrams per liter (mg/L) | Standard Deviation 0.2548 |
Secondary
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. Number Analyzed in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 407.0 micrograms per liter (mcg/L) | Standard Deviation 704.94 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 83.7 micrograms per liter (mcg/L) | Standard Deviation 144.9 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 2234.0 micrograms per liter (mcg/L) | Standard Deviation 2663.07 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 1727.3 micrograms per liter (mcg/L) | Standard Deviation 1545.92 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 33.7 micrograms per liter (mcg/L) | Standard Deviation 58.31 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 80.3 micrograms per liter (mcg/L) | Standard Deviation 139.14 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 10.3 micrograms per liter (mcg/L) | Standard Deviation 17.9 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1219.7 micrograms per liter (mcg/L) | Standard Deviation 2513.81 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 1570.0 micrograms per liter (mcg/L) | Standard Deviation 795.05 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -133.3 micrograms per liter (mcg/L) | Standard Deviation 675.45 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 1960.0 micrograms per liter (mcg/L) | Standard Deviation 2817.68 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 3626.3 micrograms per liter (mcg/L) | Standard Deviation 4819.8 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 519.7 micrograms per liter (mcg/L) | Standard Deviation 2234.46 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -170.0 micrograms per liter (mcg/L) | Standard Deviation 810.19 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -240.7 micrograms per liter (mcg/L) | Standard Deviation 1064.66 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 516.7 micrograms per liter (mcg/L) | Standard Deviation 1030.55 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -827.0 micrograms per liter (mcg/L) | Standard Deviation 1293.35 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -1214.0 micrograms per liter (mcg/L) | Standard Deviation 1129.48 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -1394.0 micrograms per liter (mcg/L) | Standard Deviation 1422.73 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -1561.0 micrograms per liter (mcg/L) | Standard Deviation 1700.71 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -937.3 micrograms per liter (mcg/L) | Standard Deviation 2577.06 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 730.0 micrograms per liter (mcg/L) | Standard Deviation 1889.87 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -780.3 micrograms per liter (mcg/L) | Standard Deviation 594.56 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -1561.0 micrograms per liter (mcg/L) | Standard Deviation 1700.71 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -1120.7 micrograms per liter (mcg/L) | Standard Deviation 2039.85 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 403.7 micrograms per liter (mcg/L) | Standard Deviation 699.17 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 1017.0 micrograms per liter (mcg/L) | Standard Deviation 1761.5 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 737.0 micrograms per liter (mcg/L) | Standard Deviation 1276.52 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0 micrograms per liter (mcg/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 2680.7 micrograms per liter (mcg/L) | Standard Deviation 2327.03 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.0 micrograms per liter (mcg/L) | Standard Deviation 0 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 507.0 micrograms per liter (mcg/L) | Standard Deviation 878.15 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.0 micrograms per liter (mcg/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.0 micrograms per liter (mcg/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 33.7 micrograms per liter (mcg/L) | Standard Deviation 58.31 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -757.0 micrograms per liter (mcg/L) | Standard Deviation 1336.62 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 4310.0 micrograms per liter (mcg/L) | Standard Deviation 3997.14 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 360.0 micrograms per liter (mcg/L) | Standard Deviation 2941.56 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -115.5 micrograms per liter (mcg/L) | Standard Deviation 3741.3 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 8 hours post-dose | -430.5 micrograms per liter (mcg/L) | Standard Deviation 3295.82 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 1650.0 micrograms per liter (mcg/L) | Standard Deviation 3691.1 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -1425.5 micrograms per liter (mcg/L) | Standard Deviation 1888.68 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -333.7 micrograms per liter (mcg/L) | Standard Deviation 1803.48 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -407.0 micrograms per liter (mcg/L) | Standard Deviation 2048.41 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 129.5 micrograms per liter (mcg/L) | Standard Deviation 1075.51 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -656.0 micrograms per liter (mcg/L) | Standard Deviation 35.36 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 8 hours post-dose | -70.0 micrograms per liter (mcg/L) | Standard Deviation 121.24 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -53.3 micrograms per liter (mcg/L) | Standard Deviation 92.38 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -173.7 micrograms per liter (mcg/L) | Standard Deviation 300.8 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 13.3 micrograms per liter (mcg/L) | Standard Deviation 23.09 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 1713.3 micrograms per liter (mcg/L) | Standard Deviation 3428.69 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -260.5 micrograms per liter (mcg/L) | Standard Deviation 368.4 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -13.3 micrograms per liter (mcg/L) | Standard Deviation 23.09 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 526.7 micrograms per liter (mcg/L) | Standard Deviation 1388.08 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -260.5 micrograms per liter (mcg/L) | Standard Deviation 368.4 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -173.7 micrograms per liter (mcg/L) | Standard Deviation 300.8 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 260.0 micrograms per liter (mcg/L) | Standard Deviation 450.33 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -173.7 micrograms per liter (mcg/L) | Standard Deviation 300.8 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 188.5 micrograms per liter (mcg/L) | Standard Deviation 296.99 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 567.2 micrograms per liter (mcg/L) | Standard Deviation 729.62 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 8 hours post-dose | 541.8 micrograms per liter (mcg/L) | Standard Deviation 844.36 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 210.2 micrograms per liter (mcg/L) | Standard Deviation 711.62 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 65.0 micrograms per liter (mcg/L) | Standard Deviation 581.79 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 530.2 micrograms per liter (mcg/L) | Standard Deviation 822.22 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 705.2 micrograms per liter (mcg/L) | Standard Deviation 1132.91 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 588.5 micrograms per liter (mcg/L) | Standard Deviation 1225.78 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 1410.5 micrograms per liter (mcg/L) | Standard Deviation 2078.58 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 131.8 micrograms per liter (mcg/L) | Standard Deviation 317.57 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 1830.8 micrograms per liter (mcg/L) | Standard Deviation 1654.01 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 1138.7 micrograms per liter (mcg/L) | Standard Deviation 2152.68 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.0 micrograms per liter (mcg/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 383.3 micrograms per liter (mcg/L) | Standard Deviation 890.52 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 518.3 micrograms per liter (mcg/L) | Standard Deviation 752.66 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.0 micrograms per liter (mcg/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0 micrograms per liter (mcg/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -536.4 micrograms per liter (mcg/L) | Standard Deviation 602.28 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 1062.2 micrograms per liter (mcg/L) | Standard Deviation 2324.85 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 1418.5 micrograms per liter (mcg/L) | Standard Deviation 2194.12 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 876.7 micrograms per liter (mcg/L) | Standard Deviation 993.91 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 2330.3 micrograms per liter (mcg/L) | Standard Deviation 3100.19 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 295.2 micrograms per liter (mcg/L) | Standard Deviation 739.73 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1348.5 micrograms per liter (mcg/L) | Standard Deviation 1359.62 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 5: 96 hours post-dose | 475.8 micrograms per liter (mcg/L) | Standard Deviation 777.97 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -1133.7 micrograms per liter (mcg/L) | Standard Deviation 1614.09 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -170.2 micrograms per liter (mcg/L) | Standard Deviation 796.82 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -1734.6 micrograms per liter (mcg/L) | Standard Deviation 1602.72 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -583.5 micrograms per liter (mcg/L) | Standard Deviation 1326.1 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -548.5 micrograms per liter (mcg/L) | Standard Deviation 1846.32 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -1298.4 micrograms per liter (mcg/L) | Standard Deviation 1672.16 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -640.5 micrograms per liter (mcg/L) | Standard Deviation 1839.01 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 5: 96 hours post-dose | -252.2 micrograms per liter (mcg/L) | Standard Deviation 2190.36 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -1078.2 micrograms per liter (mcg/L) | Standard Deviation 1941.86 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -688.0 micrograms per liter (mcg/L) | Standard Deviation 2313.92 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1093.7 micrograms per liter (mcg/L) | Standard Deviation 1681.6 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 693.3 micrograms per liter (mcg/L) | Standard Deviation 1200.89 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 710.0 micrograms per liter (mcg/L) | Standard Deviation 1229.76 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 440.0 micrograms per liter (mcg/L) | Standard Deviation 762.1 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -76.7 micrograms per liter (mcg/L) | Standard Deviation 132.79 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 693.3 micrograms per liter (mcg/L) | Standard Deviation 1200.89 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 156.7 micrograms per liter (mcg/L) | Standard Deviation 271.35 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 383.3 micrograms per liter (mcg/L) | Standard Deviation 663.95 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 330.0 micrograms per liter (mcg/L) | Standard Deviation 571.58 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 5: 96 hours post-dose | -346.7 micrograms per liter (mcg/L) | Standard Deviation 600.44 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 436.1 micrograms per liter (mcg/L) | Standard Deviation 1343.41 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -70.7 micrograms per liter (mcg/L) | Standard Deviation 1343.24 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -77.6 micrograms per liter (mcg/L) | Standard Deviation 766.58 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 470.0 micrograms per liter (mcg/L) | Standard Deviation 3018.14 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 262.4 micrograms per liter (mcg/L) | Standard Deviation 1096.43 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -187.4 micrograms per liter (mcg/L) | Standard Deviation 1055.28 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -162.0 micrograms per liter (mcg/L) | Standard Deviation 767.87 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 174.3 micrograms per liter (mcg/L) | Standard Deviation 1669.5 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -364.0 micrograms per liter (mcg/L) | Standard Deviation 937.82 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 5: 96 hours post-dose | 788.2 micrograms per liter (mcg/L) | Standard Deviation 2632.47 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 569.3 micrograms per liter (mcg/L) | Standard Deviation 1040.58 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -425.1 micrograms per liter (mcg/L) | Standard Deviation 779.62 |
| Placebo | Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints | Day 1: 8 hours post-dose | -176.0 micrograms per liter (mcg/L) | Standard Deviation 393.55 |
Secondary
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. Number Analyzed in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.907 mcg/L | Standard Deviation 0.6881 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 2.077 mcg/L | Standard Deviation 1.8309 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.870 mcg/L | Standard Deviation 0.2343 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.623 mcg/L | Standard Deviation 0.4709 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.027 mcg/L | Standard Deviation 0.0379 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 2.023 mcg/L | Standard Deviation 1.8553 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 3.230 mcg/L | Standard Deviation 6.0836 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.290 mcg/L | Standard Deviation 1.313 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.987 mcg/L | Standard Deviation 0.9901 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -1.083 mcg/L | Standard Deviation 1.1453 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 2.310 mcg/L | Standard Deviation 4.7039 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.057 mcg/L | Standard Deviation 0.9869 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 4.413 mcg/L | Standard Deviation 9.3654 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -1.280 mcg/L | Standard Deviation 1.1086 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.730 mcg/L | Standard Deviation 2.6751 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.167 mcg/L | Standard Deviation 1.6862 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 1.077 mcg/L | Standard Deviation 3.6656 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 3.907 mcg/L | Standard Deviation 6.9842 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.107 mcg/L | Standard Deviation 0.5805 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.003 mcg/L | Standard Deviation 0.6153 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.287 mcg/L | Standard Deviation 0.7174 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.113 mcg/L | Standard Deviation 0.2747 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.067 mcg/L | Standard Deviation 0.315 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.213 mcg/L | Standard Deviation 0.2676 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.323 mcg/L | Standard Deviation 0.7149 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.360 mcg/L | Standard Deviation 0.4004 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.040 mcg/L | Standard Deviation 0.2862 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.657 mcg/L | Standard Deviation 1.7796 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.667 mcg/L | Standard Deviation 0.7332 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.283 mcg/L | Standard Deviation 0.6417 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 2.713 mcg/L | Standard Deviation 4.5502 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.067 mcg/L | Standard Deviation 1.1829 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -1.140 mcg/L | Standard Deviation 1.2813 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.983 mcg/L | Standard Deviation 0.7184 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.257 mcg/L | Standard Deviation 1.7737 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.833 mcg/L | Standard Deviation 3.0087 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.330 mcg/L | Standard Deviation 0.1015 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.627 mcg/L | Standard Deviation 0.2098 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.827 mcg/L | Standard Deviation 0.4311 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.930 mcg/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 2.043 mcg/L | Standard Deviation 2.411 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.317 mcg/L | Standard Deviation 0.3281 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.680 mcg/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.710 mcg/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 1.617 mcg/L | Standard Deviation 0.8663 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 3.717 mcg/L | Standard Deviation 3.8882 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.655 mcg/L | Standard Deviation 0.0071 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.613 mcg/L | Standard Deviation 0.0643 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.485 mcg/L | Standard Deviation 0.2475 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 8 hours post-dose | -0.445 mcg/L | Standard Deviation 0.3041 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.605 mcg/L | Standard Deviation 0.0778 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.670 mcg/L | Standard Deviation 0.0141 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.403 mcg/L | Standard Deviation 0.3194 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.423 mcg/L | Standard Deviation 0.3927 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.643 mcg/L | Standard Deviation 0.0153 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.550 mcg/L | Standard Deviation 0.1273 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.660 mcg/L | Standard Deviation 0.0283 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.000 mcg/L | Standard Deviation 0 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.127 mcg/L | Standard Deviation 0.1115 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.027 mcg/L | Standard Deviation 0.0462 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.197 mcg/L | Standard Deviation 0.3406 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.190 mcg/L | Standard Deviation 0.3291 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.085 mcg/L | Standard Deviation 0.1202 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.083 mcg/L | Standard Deviation 0.1193 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.210 mcg/L | Standard Deviation 0.3637 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.580 mcg/L | Standard Deviation 1.1549 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.013 mcg/L | Standard Deviation 0.0231 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.163 mcg/L | Standard Deviation 0.2829 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.023 mcg/L | Standard Deviation 0.0681 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.233 mcg/L | Standard Deviation 0.7781 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 10.358 mcg/L | Standard Deviation 18.0554 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.153 mcg/L | Standard Deviation 0.4864 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 2.898 mcg/L | Standard Deviation 7.8222 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.217 mcg/L | Standard Deviation 0.3525 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.283 mcg/L | Standard Deviation 0.694 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.183 mcg/L | Standard Deviation 0.4491 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.282 mcg/L | Standard Deviation 0.7349 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.062 mcg/L | Standard Deviation 0.817 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 8 hours post-dose | -0.275 mcg/L | Standard Deviation 0.7237 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 2.277 mcg/L | Standard Deviation 6.9301 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.220 mcg/L | Standard Deviation 0.7804 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | 11.300 mcg/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -4.413 mcg/L | Standard Deviation 6.3713 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.142 mcg/L | Standard Deviation 8.3021 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 8 hours post-dose | 7.700 mcg/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -9.218 mcg/L | Standard Deviation 13.7046 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.327 mcg/L | Standard Deviation 9.5142 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 5: 96 hours post-dose | 10.166 mcg/L | Standard Deviation 15.4306 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 4.102 mcg/L | Standard Deviation 6.1943 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 13.542 mcg/L | Standard Deviation 20.3702 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -11.698 mcg/L | Standard Deviation 14.0227 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | 5.300 mcg/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -10.962 mcg/L | Standard Deviation 14.6454 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.767 mcg/L | Standard Deviation 9.8244 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.080 mcg/L | Standard Deviation 1.3326 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.456 mcg/L | Standard Deviation 0.878 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.235 mcg/L | Standard Deviation 0.6678 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.703 mcg/L | Standard Deviation 1.905 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.383 mcg/L | Standard Deviation 0.9286 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.284 mcg/L | Standard Deviation 0.4548 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.452 mcg/L | Standard Deviation 0.7897 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.177 mcg/L | Standard Deviation 0.7212 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.035 mcg/L | Standard Deviation 0.7219 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.425 mcg/L | Standard Deviation 0.8435 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -0.310 mcg/L | Standard Deviation 0.5112 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.143 mcg/L | Standard Deviation 0.2658 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.283 mcg/L | Standard Deviation 0.5346 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.410 mcg/L | Standard Deviation 0.3996 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.150 mcg/L | Standard Deviation 0.6874 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.043 mcg/L | Standard Deviation 0.4466 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.257 mcg/L | Standard Deviation 1 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.380 mcg/L | Standard Deviation 0.5027 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.293 mcg/L | Standard Deviation 0.624 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.473 mcg/L | Standard Deviation 0.9347 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.307 mcg/L | Standard Deviation 0.4571 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.001 mcg/L | Standard Deviation 1.701 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.219 mcg/L | Standard Deviation 1.3316 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.015 mcg/L | Standard Deviation 0.5437 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.398 mcg/L | Standard Deviation 1.5906 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.044 mcg/L | Standard Deviation 0.6347 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.081 mcg/L | Standard Deviation 1.1008 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.183 mcg/L | Standard Deviation 0.8073 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 8 hours post-dose | -0.130 mcg/L | Standard Deviation 0.4181 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.312 mcg/L | Standard Deviation 0.5937 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 1.984 mcg/L | Standard Deviation 4.3754 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.464 mcg/L | Standard Deviation 1.5409 |
| Placebo | Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.176 mcg/L | Standard Deviation 1.082 |
Secondary
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Population: All enrolled participants treated who had at least 1 measurement of the exploratory endpoints of interest. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable results for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 5.400 nanograms per liter (ng/L) | Standard Deviation 11.984 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.303 nanograms per liter (ng/L) | Standard Deviation 0.095 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | 25.507 nanograms per liter (ng/L) | Standard Deviation 44.6205 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | 2.877 nanograms per liter (ng/L) | Standard Deviation 8.4727 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.413 nanograms per liter (ng/L) | Standard Deviation 3.6272 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.817 nanograms per liter (ng/L) | Standard Deviation 2.8587 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.430 nanograms per liter (ng/L) | Standard Deviation 2.1622 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.440 nanograms per liter (ng/L) | Standard Deviation 0.7134 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.383 nanograms per liter (ng/L) | Standard Deviation 1.2687 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -8.260 nanograms per liter (ng/L) | Standard Deviation 13.1193 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | -11.603 nanograms per liter (ng/L) | Standard Deviation 18.4042 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -10.640 nanograms per liter (ng/L) | Standard Deviation 16.1897 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -4.893 nanograms per liter (ng/L) | Standard Deviation 8.0609 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.293 nanograms per liter (ng/L) | Standard Deviation 3.4514 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | -1.750 nanograms per liter (ng/L) | Standard Deviation 4.2354 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | -1.227 nanograms per liter (ng/L) | Standard Deviation 5.1897 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -3.230 nanograms per liter (ng/L) | Standard Deviation 5.0126 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | -4.707 nanograms per liter (ng/L) | Standard Deviation 8.0587 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.403 nanograms per liter (ng/L) | Standard Deviation 0.8138 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.510 nanograms per liter (ng/L) | Standard Deviation 0.7119 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.487 nanograms per liter (ng/L) | Standard Deviation 0.7658 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | 24.490 nanograms per liter (ng/L) | Standard Deviation 22.6078 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 16.790 nanograms per liter (ng/L) | Standard Deviation 13.5079 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.337 nanograms per liter (ng/L) | Standard Deviation 0.5686 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.433 nanograms per liter (ng/L) | Standard Deviation 1.0587 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | 1.240 nanograms per liter (ng/L) | Standard Deviation 1.0792 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.083 nanograms per liter (ng/L) | Standard Deviation 0.1893 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.097 nanograms per liter (ng/L) | Standard Deviation 0.3807 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 21.467 nanograms per liter (ng/L) | Standard Deviation 11.4311 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.363 nanograms per liter (ng/L) | Standard Deviation 0.3702 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | 50.667 nanograms per liter (ng/L) | Standard Deviation 29.7923 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.317 nanograms per liter (ng/L) | Standard Deviation 0.3868 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.050 nanograms per liter (ng/L) | Standard Deviation 0.5766 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.230 nanograms per liter (ng/L) | Standard Deviation 0.3279 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.497 nanograms per liter (ng/L) | Standard Deviation 0.4405 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | 3.903 nanograms per liter (ng/L) | Standard Deviation 3.7969 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 8 hours post-dose | 86.700 nanograms per liter (ng/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 160.287 nanograms per liter (ng/L) | Standard Deviation 157.2547 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 32.100 nanograms per liter (ng/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -16.247 nanograms per liter (ng/L) | Standard Deviation 28.1401 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -15.327 nanograms per liter (ng/L) | Standard Deviation 26.5466 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.000 nanograms per liter (ng/L) | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | 20.240 nanograms per liter (ng/L) | Standard Deviation 14.2259 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | -8.733 nanograms per liter (ng/L) | Standard Deviation 15.1266 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | 292.287 nanograms per liter (ng/L) | Standard Deviation 233.1423 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | -12.533 nanograms per liter (ng/L) | Standard Deviation 21.7084 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | 26.157 nanograms per liter (ng/L) | Standard Deviation 17.0904 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 41.575 nanograms per liter (ng/L) | Standard Deviation 15.6624 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 8 hours post-dose | 9.975 nanograms per liter (ng/L) | Standard Deviation 1.591 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 4.125 nanograms per liter (ng/L) | Standard Deviation 7.955 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 21.075 nanograms per liter (ng/L) | Standard Deviation 44.2295 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 2.663 nanograms per liter (ng/L) | Standard Deviation 14.6931 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -3.290 nanograms per liter (ng/L) | Standard Deviation 3.3698 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.960 nanograms per liter (ng/L) | Standard Deviation 7.2832 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.900 nanograms per liter (ng/L) | Standard Deviation 9.2772 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | 250.257 nanograms per liter (ng/L) | Standard Deviation 301.349 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -3.660 nanograms per liter (ng/L) | Standard Deviation 5.9789 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 8 hours post-dose | 1.373 nanograms per liter (ng/L) | Standard Deviation 1.9731 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 2.340 nanograms per liter (ng/L) | Standard Deviation 3.199 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.223 nanograms per liter (ng/L) | Standard Deviation 1.2471 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.403 nanograms per liter (ng/L) | Standard Deviation 0.4239 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | 1.197 nanograms per liter (ng/L) | Standard Deviation 2.2445 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.160 nanograms per liter (ng/L) | Standard Deviation 1.5159 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.423 nanograms per liter (ng/L) | Standard Deviation 0.2454 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | 2.985 nanograms per liter (ng/L) | Standard Deviation 2.8214 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 2.477 nanograms per liter (ng/L) | Standard Deviation 2.833 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.853 nanograms per liter (ng/L) | Standard Deviation 0.204 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.005 nanograms per liter (ng/L) | Standard Deviation 0.2475 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 2.820 nanograms per liter (ng/L) | Standard Deviation 5.9672 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.145 nanograms per liter (ng/L) | Standard Deviation 0.8771 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -5.755 nanograms per liter (ng/L) | Standard Deviation 12.4057 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 8 hours post-dose | 5.012 nanograms per liter (ng/L) | Standard Deviation 12.0362 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -3.900 nanograms per liter (ng/L) | Standard Deviation 12.0196 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 4.155 nanograms per liter (ng/L) | Standard Deviation 10.1704 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | -5.598 nanograms per liter (ng/L) | Standard Deviation 11.5371 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 4.230 nanograms per liter (ng/L) | Standard Deviation 7.9003 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -2.492 nanograms per liter (ng/L) | Standard Deviation 8.4374 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.295 nanograms per liter (ng/L) | Standard Deviation 0.852 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 1.333 nanograms per liter (ng/L) | Standard Deviation 4.4335 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 2.402 nanograms per liter (ng/L) | Standard Deviation 2.8296 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -5.550 nanograms per liter (ng/L) | Standard Deviation 12.2071 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -1.864 nanograms per liter (ng/L) | Standard Deviation 3.5365 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 3.322 nanograms per liter (ng/L) | Standard Deviation 2.189 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.030 nanograms per liter (ng/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | 5.650 nanograms per liter (ng/L) | Standard Deviation 12.4743 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.330 nanograms per liter (ng/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 11.207 nanograms per liter (ng/L) | Standard Deviation 5.8049 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 8 hours post-dose | 14.400 nanograms per liter (ng/L) | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 2.937 nanograms per liter (ng/L) | Standard Deviation 3.8441 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -2.120 nanograms per liter (ng/L) | Standard Deviation 4.001 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 4.403 nanograms per liter (ng/L) | Standard Deviation 5.7437 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.968 nanograms per liter (ng/L) | Standard Deviation 2.5824 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -2.040 nanograms per liter (ng/L) | Standard Deviation 3.6754 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.558 nanograms per liter (ng/L) | Standard Deviation 2.0766 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.082 nanograms per liter (ng/L) | Standard Deviation 1.6527 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 53.540 nanograms per liter (ng/L) | Standard Deviation 65.4359 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 12.345 nanograms per liter (ng/L) | Standard Deviation 4.5839 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 3.283 nanograms per liter (ng/L) | Standard Deviation 1.6786 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.133 nanograms per liter (ng/L) | Standard Deviation 0.9903 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 1.563 nanograms per liter (ng/L) | Standard Deviation 0.9806 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.552 nanograms per liter (ng/L) | Standard Deviation 1.078 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 5: 96 hours post-dose | 8.516 nanograms per liter (ng/L) | Standard Deviation 15.1062 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.344 nanograms per liter (ng/L) | Standard Deviation 0.9542 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.188 nanograms per liter (ng/L) | Standard Deviation 1.5621 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 5: 96 hours post-dose | -6.123 nanograms per liter (ng/L) | Standard Deviation 10.0962 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | 14.793 nanograms per liter (ng/L) | Standard Deviation 7.5312 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | -5.457 nanograms per liter (ng/L) | Standard Deviation 9.9449 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | -6.063 nanograms per liter (ng/L) | Standard Deviation 10.1365 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | -5.300 nanograms per liter (ng/L) | Standard Deviation 9.5979 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | -2.833 nanograms per liter (ng/L) | Standard Deviation 4.3584 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -4.830 nanograms per liter (ng/L) | Standard Deviation 10.814 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | -3.257 nanograms per liter (ng/L) | Standard Deviation 9.1184 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | 8.327 nanograms per liter (ng/L) | Standard Deviation 6.7983 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | -4.397 nanograms per liter (ng/L) | Standard Deviation 7.4304 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.713 nanograms per liter (ng/L) | Standard Deviation 5.8229 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 36: 840 hours post-dose | 1.276 nanograms per liter (ng/L) | Standard Deviation 3.1066 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 8 hours post-dose | -0.422 nanograms per liter (ng/L) | Standard Deviation 0.4181 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.337 nanograms per liter (ng/L) | Standard Deviation 0.7686 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.155 nanograms per liter (ng/L) | Standard Deviation 0.8139 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 5: 96 hours post-dose | 1.118 nanograms per liter (ng/L) | Standard Deviation 1.538 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 8: 168 hours post-dose | 1.006 nanograms per liter (ng/L) | Standard Deviation 3.81 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.554 nanograms per liter (ng/L) | Standard Deviation 0.4981 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 3: 48 hours post-dose | 12.843 nanograms per liter (ng/L) | Standard Deviation 50.7623 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 4: 72 hours post-dose | 27.946 nanograms per liter (ng/L) | Standard Deviation 111.802 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 2: 24 hours post-dose | 1.027 nanograms per liter (ng/L) | Standard Deviation 3.3372 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.448 nanograms per liter (ng/L) | Standard Deviation 0.4631 |
| Placebo | Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 1.019 nanograms per liter (ng/L) | Standard Deviation 0.8362 |
Secondary
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. Number Analyzed in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.7137 ng/L | Standard Deviation 0.53129 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.3813 ng/L | Standard Deviation 0.66049 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0177 ng/L | Standard Deviation 0.0306 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.8893 ng/L | Standard Deviation 0.97631 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0787 ng/L | Standard Deviation 0.13625 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.0817 ng/L | Standard Deviation 0.14145 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0847 ng/L | Standard Deviation 0.11301 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.3947 ng/L | Standard Deviation 0.68358 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.7927 ng/L | Standard Deviation 1.36082 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.0247 ng/L | Standard Deviation 0.04272 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.0207 ng/L | Standard Deviation 0.08003 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.3280 ng/L | Standard Deviation 0.33207 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.3010 ng/L | Standard Deviation 0.30959 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.1570 ng/L | Standard Deviation 0.27193 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.1917 ng/L | Standard Deviation 0.24744 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.0063 ng/L | Standard Deviation 0.04087 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.6083 ng/L | Standard Deviation 0.46302 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.0310 ng/L | Standard Deviation 0.05369 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 5.4180 ng/L | Standard Deviation 6.21463 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 4.7613 ng/L | Standard Deviation 5.00708 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0743 ng/L | Standard Deviation 0.12009 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.3590 ng/L | Standard Deviation 0.27029 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0927 ng/L | Standard Deviation 0.10203 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.1563 ng/L | Standard Deviation 0.15264 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0727 ng/L | Standard Deviation 0.06972 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.0087 ng/L | Standard Deviation 0.0125 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.2260 ng/L | Standard Deviation 0.2301 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0120 ng/L | Standard Deviation 0.4405 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.1040 ng/L | Standard Deviation 0.09938 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0340 ng/L | Standard Deviation 0.05889 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.0960 ng/L | Standard Deviation 0.16628 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 24.9907 ng/L | Standard Deviation 28.82106 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 2.1150 ng/L | Standard Deviation 3.5077 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.9653 ng/L | Standard Deviation 1.35472 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 10.7307 ng/L | Standard Deviation 5.75904 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.8647 ng/L | Standard Deviation 0.93571 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.6127 ng/L | Standard Deviation 1.06117 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.0667 ng/L | Standard Deviation 0.11547 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 1261.782 ng/L | Standard Deviation 1377.243 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0070 ng/L | Standard Deviation 0.23658 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 6.4480 ng/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 8 hours post-dose | 35.2980 ng/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0000 ng/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.6757 ng/L | Standard Deviation 0.8053 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 817.4487 ng/L | Standard Deviation 952.5663 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.3100 ng/L | Standard Deviation 0.6562 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.1375 ng/L | Standard Deviation 0.81529 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | -0.0495 ng/L | Standard Deviation 0.55084 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.1203 ng/L | Standard Deviation 0.27872 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 2.1110 ng/L | Standard Deviation 2.86966 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.1297 ng/L | Standard Deviation 0.26905 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 365.8777 ng/L | Standard Deviation 534.9345 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 16.1545 ng/L | Standard Deviation 9.4321 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | -0.0937 ng/L | Standard Deviation 0.30933 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.5620 ng/L | Standard Deviation 0.79479 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.4090 ng/L | Standard Deviation 0.31213 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.2863 ng/L | Standard Deviation 0.13785 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.5713 ng/L | Standard Deviation 0.98958 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.7460 ng/L | Standard Deviation 0.42248 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.2970 ng/L | Standard Deviation 0.31973 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0105 ng/L | Standard Deviation 0.01485 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.4147 ng/L | Standard Deviation 0.71822 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.1830 ng/L | Standard Deviation 0.16928 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 2.3943 ng/L | Standard Deviation 2.26382 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.1143 ng/L | Standard Deviation 0.22064 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.0255 ng/L | Standard Deviation 0.077 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0298 ng/L | Standard Deviation 0.08751 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 3.3927 ng/L | Standard Deviation 1.80711 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 2.8793 ng/L | Standard Deviation 2.33024 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.2665 ng/L | Standard Deviation 0.38316 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.0047 ng/L | Standard Deviation 0.01143 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.2855 ng/L | Standard Deviation 0.60079 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0780 ng/L | Standard Deviation 0.10187 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 8 hours post-dose | 3.1483 ng/L | Standard Deviation 4.27777 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 3.5448 ng/L | Standard Deviation 3.52636 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 1.9242 ng/L | Standard Deviation 2.2319 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.1410 ng/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 1.1740 ng/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1.7130 ng/L | Standard Deviation 2.18458 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.2730 ng/L | Standard Deviation 0.29167 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.2382 ng/L | Standard Deviation 0.53605 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.0834 ng/L | Standard Deviation 0.73122 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 8 hours post-dose | 1.7440 ng/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 2.1285 ng/L | Standard Deviation 4.43835 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0100 ng/L | Standard Deviation 0.8168 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.0998 ng/L | Standard Deviation 0.40069 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.1396 ng/L | Standard Deviation 0.23005 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 71: 1680 hours post-dose | -0.0758 ng/L | Standard Deviation 0.61407 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.0957 ng/L | Standard Deviation 0.13221 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 1.2097 ng/L | Standard Deviation 0.72824 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.1062 ng/L | Standard Deviation 0.13652 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 5: 96 hours post-dose | 1.7690 ng/L | Standard Deviation 3.78958 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0284 ng/L | Standard Deviation 0.0635 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 53.7213 ng/L | Standard Deviation 107.2734 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0774 ng/L | Standard Deviation 0.17307 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0155 ng/L | Standard Deviation 0.03797 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0180 ng/L | Standard Deviation 0.03118 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.0277 ng/L | Standard Deviation 0.04792 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.6550 ng/L | Standard Deviation 0.33707 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.2030 ng/L | Standard Deviation 0.35161 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0710 ng/L | Standard Deviation 0.12298 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.0157 ng/L | Standard Deviation 0.02714 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.2797 ng/L | Standard Deviation 0.4844 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 11.1390 ng/L | Standard Deviation 16.70153 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.5043 ng/L | Standard Deviation 0.80624 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 1.3477 ng/L | Standard Deviation 2.13897 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.6368 ng/L | Standard Deviation 0.62657 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 71: 1680 hours post-dose | 0.0539 ng/L | Standard Deviation 0.16145 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.0282 ng/L | Standard Deviation 0.56396 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.0000 ng/L | Standard Deviation 0 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.1368 ng/L | Standard Deviation 0.81459 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.0737 ng/L | Standard Deviation 0.43828 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0974 ng/L | Standard Deviation 0.35056 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.1433 ng/L | Standard Deviation 0.20404 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.3799 ng/L | Standard Deviation 0.63486 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0861 ng/L | Standard Deviation 0.15271 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.3684 ng/L | Standard Deviation 0.77453 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0120 ng/L | Standard Deviation 0.07478 |
| Placebo | Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.2653 ng/L | Standard Deviation 0.48087 |
Secondary
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Population: All enrolled subjects treated who had at least 1 measurement of the exploratory endpoints of interest. Number Analyzed in each row will be 0 if no participant had at least 1 measurement of the exploratory endpoints of interest within the specified timeframe.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.0833 ng/L | Standard Deviation 0.08505 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.1600 ng/L | Standard Deviation 0.38974 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.0433 ng/L | Standard Deviation 0.44004 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.2200 ng/L | Standard Deviation 0.30447 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | -0.1100 ng/L | Standard Deviation 0.21932 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.1833 ng/L | Standard Deviation 0.37873 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.2567 ng/L | Standard Deviation 0.0611 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.0500 ng/L | Standard Deviation 0.06 |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.3233 ng/L | Standard Deviation 0.21733 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.0667 ng/L | Standard Deviation 0.31565 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.5767 ng/L | Standard Deviation 0.9947 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.0567 ng/L | Standard Deviation 0.31501 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.1333 ng/L | Standard Deviation 0.27062 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.4567 ng/L | Standard Deviation 0.21939 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.3633 ng/L | Standard Deviation 0.52205 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0333 ng/L | Standard Deviation 0.21362 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.0167 ng/L | Standard Deviation 0.39954 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.4133 ng/L | Standard Deviation 0.56722 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.5033 ng/L | Standard Deviation 0.71501 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 1.3067 ng/L | Standard Deviation 0.25325 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.1867 ng/L | Standard Deviation 0.54647 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.4867 ng/L | Standard Deviation 0.965 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.2767 ng/L | Standard Deviation 0.32929 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.6533 ng/L | Standard Deviation 0.83032 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.5967 ng/L | Standard Deviation 0.17559 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 10.7767 ng/L | Standard Deviation 10.67258 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 5.8100 ng/L | Standard Deviation 3.05779 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.0667 ng/L | Standard Deviation 0.4373 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.1233 ng/L | Standard Deviation 0.10017 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.8700 ng/L | Standard Deviation 0.09644 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0933 ng/L | Standard Deviation 0.54151 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | -0.1467 ng/L | Standard Deviation 0.3247 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 20.4567 ng/L | Standard Deviation 7.74517 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 9.0900 ng/L | Standard Deviation 1.62613 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.2633 ng/L | Standard Deviation 0.63129 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 4.8733 ng/L | Standard Deviation 3.27147 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 2.8000 ng/L | Standard Deviation 1.2579 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.4967 ng/L | Standard Deviation 0.30022 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 59.7100 ng/L | Standard Deviation 34.37035 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.2300 ng/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 49.6433 ng/L | Standard Deviation 18.57913 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 8 hours post-dose | 23.8900 ng/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 217.9767 ng/L | Standard Deviation 78.32721 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 11.0900 ng/L | — |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.0900 ng/L | Standard Deviation 0.22539 |
| Cohort 5: PF-06755347 1 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0267 ng/L | Standard Deviation 0.31342 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 2.7700 ng/L | Standard Deviation 1.41421 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 97.4267 ng/L | Standard Deviation 89.3124 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | -0.5810 ng/L | Standard Deviation 0.96308 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.2233 ng/L | Standard Deviation 0.3213 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 1.6150 ng/L | Standard Deviation 1.77484 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.7100 ng/L | Standard Deviation 1.04159 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 38.5200 ng/L | Standard Deviation 29.6979 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | -1.2265 ng/L | Standard Deviation 0.1591 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 8 hours post-dose | 5.6750 ng/L | Standard Deviation 2.41123 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.7533 ng/L | Standard Deviation 1.52998 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 15.6900 ng/L | Standard Deviation 4.25678 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.0650 ng/L | Standard Deviation 0.41154 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.1383 ng/L | Standard Deviation 0.05777 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | -0.0250 ng/L | Standard Deviation 0.06051 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.0327 ng/L | Standard Deviation 0.08016 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.0673 ng/L | Standard Deviation 0.10808 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.3103 ng/L | Standard Deviation 0.37419 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.4367 ng/L | Standard Deviation 0.48959 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0883 ng/L | Standard Deviation 0.06213 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.0227 ng/L | Standard Deviation 0.12889 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.0350 ng/L | Standard Deviation 0.12758 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.1685 ng/L | Standard Deviation 0.26092 |
| Cohort 7: PF-06755347 25 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 71: 840 hours post-dose | 0.1363 ng/L | Standard Deviation 0.25455 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.3792 ng/L | Standard Deviation 0.53143 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0048 ng/L | Standard Deviation 0.06199 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.4748 ng/L | Standard Deviation 0.44527 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.5760 ng/L | Standard Deviation 1.36848 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.1905 ng/L | Standard Deviation 0.27975 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.1182 ng/L | Standard Deviation 0.2036 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 71: 840 hours post-dose | 0.5913 ng/L | Standard Deviation 0.28774 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.2715 ng/L | Standard Deviation 0.369 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0383 ng/L | Standard Deviation 0.17292 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 0.4453 ng/L | Standard Deviation 0.65376 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 8 hours post-dose | 0.6442 ng/L | Standard Deviation 1.36307 |
| Cohort 8: PF-06755347 50 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.1830 ng/L | Standard Deviation 0.20827 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | -0.0317 ng/L | Standard Deviation 0.17725 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.1200 ng/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 71: 840 hours post-dose | -0.0340 ng/L | Standard Deviation 0.25211 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 1.1792 ng/L | Standard Deviation 0.71557 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 8 hours post-dose | 1.7800 ng/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | 0.2776 ng/L | Standard Deviation 0.56067 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.2665 ng/L | Standard Deviation 0.14113 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.3600 ng/L | — |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.5225 ng/L | Standard Deviation 0.24791 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.1820 ng/L | Standard Deviation 0.1006 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0280 ng/L | Standard Deviation 0.16664 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 0.3422 ng/L | Standard Deviation 0.43494 |
| Cohort 9: PF-06755347 100 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.9425 ng/L | Standard Deviation 0.50586 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.1644 ng/L | Standard Deviation 0.148 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.5575 ng/L | Standard Deviation 0.24078 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0310 ng/L | Standard Deviation 0.12138 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 71: 840 hours post-dose | -0.1698 ng/L | Standard Deviation 0.206 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.1340 ng/L | Standard Deviation 0.19649 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.1608 ng/L | Standard Deviation 0.17623 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 1.7025 ng/L | Standard Deviation 0.7145 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 1.0875 ng/L | Standard Deviation 0.40787 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 10.4592 ng/L | Standard Deviation 16.00977 |
| Cohort 10: PF-06755347 200 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0098 ng/L | Standard Deviation 0.04696 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.0040 ng/L | Standard Deviation 0.0233 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 71: 840 hours post-dose | 0.1327 ng/L | Standard Deviation 0.19433 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.4237 ng/L | Standard Deviation 0.06199 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.3293 ng/L | Standard Deviation 0.11039 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 5: 96 hours post-dose | 0.2643 ng/L | Standard Deviation 0.06914 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.7370 ng/L | Standard Deviation 0.1912 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.1697 ng/L | Standard Deviation 0.05604 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | 1.3270 ng/L | Standard Deviation 0.18793 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | 1.7770 ng/L | Standard Deviation 0.92867 |
| Cohort 11: PF-06755347 300 mg SC | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.1297 ng/L | Standard Deviation 0.30426 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 12 hours post-dose | -0.1489 ng/L | Standard Deviation 0.1355 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 8: 168 hours post-dose | 0.0237 ng/L | Standard Deviation 0.20192 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 2: 24 hours post-dose | 0.0585 ng/L | Standard Deviation 0.13732 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 5: 96 hours post-dose | -0.0080 ng/L | Standard Deviation 0.10568 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 3 hours post-dose | 0.0198 ng/L | Standard Deviation 0.12203 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 15: 336 hours post-dose | 0.0909 ng/L | Standard Deviation 0.49582 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 4: 72 hours post-dose | 0.2039 ng/L | Standard Deviation 0.73037 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 3: 48 hours post-dose | 0.0784 ng/L | Standard Deviation 0.29068 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 36: 840 hours post-dose | -0.0090 ng/L | Standard Deviation 0.85788 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 71: 840 hours post-dose | -0.0820 ng/L | Standard Deviation 0.24109 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 8 hours post-dose | -0.1326 ng/L | Standard Deviation 0.13676 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 5 hours post-dose | -0.1024 ng/L | Standard Deviation 0.08281 |
| Placebo | Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints | Day 1: 1 hour post-dose | 0.0055 ng/L | Standard Deviation 0.11117 |
Secondary
Clearance (CL) of PF-06755347 Following Single IV Dose
CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: PF-06755347 0.03 mg/kg IV | Clearance (CL) of PF-06755347 Following Single IV Dose | 0.002397 L/hr/kg | Geometric Coefficient of Variation 25 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Clearance (CL) of PF-06755347 Following Single IV Dose | 0.002027 L/hr/kg | Geometric Coefficient of Variation 10 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Clearance (CL) of PF-06755347 Following Single IV Dose | 0.001846 L/hr/kg | Geometric Coefficient of Variation 8 |
| Cohort 5: PF-06755347 1 mg/kg IV | Clearance (CL) of PF-06755347 Following Single IV Dose | 0.001758 L/hr/kg | Geometric Coefficient of Variation 29 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Clearance (CL) of PF-06755347 Following Single IV Dose | NA L/hr/kg | — |
Secondary
Cmax(dn) of PF-06755347 Following Single SC Dose
Cmax(dn) = Cmax/Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Cmax(dn) of PF-06755347 Following Single SC Dose | 0.03579 ug/mL/(mg/kg) | Geometric Coefficient of Variation 25 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Cmax(dn) of PF-06755347 Following Single SC Dose | 0.02748 ug/mL/(mg/kg) | Geometric Coefficient of Variation 68 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Cmax(dn) of PF-06755347 Following Single SC Dose | 0.02641 ug/mL/(mg/kg) | Geometric Coefficient of Variation 40 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Cmax(dn) of PF-06755347 Following Single SC Dose | 0.02842 ug/mL/(mg/kg) | Geometric Coefficient of Variation 15 |
| Cohort 5: PF-06755347 1 mg/kg IV | Cmax(dn) of PF-06755347 Following Single SC Dose | 5.276 ug/mL/(mg/kg) | Geometric Coefficient of Variation 0.01758 |
Secondary
Cmax of PF-06755347 Following Single SC Dose
Cmax was the highest concentration observed directly from data
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Cmax of PF-06755347 Following Single SC Dose | 0.8946 ug/mL | Geometric Coefficient of Variation 25 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Cmax of PF-06755347 Following Single SC Dose | 1.374 ug/mL | Geometric Coefficient of Variation 68 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Cmax of PF-06755347 Following Single SC Dose | 2.641 ug/mL | Geometric Coefficient of Variation 40 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Cmax of PF-06755347 Following Single SC Dose | 5.678 ug/mL | Geometric Coefficient of Variation 15 |
| Cohort 5: PF-06755347 1 mg/kg IV | Cmax of PF-06755347 Following Single SC Dose | 5.276 ug/mL | Geometric Coefficient of Variation 47 |
Secondary
Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose
AUCinf(dn) = AUCinf/Dose
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: PF-06755347 0.03 mg/kg IV | Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | 417.5 ug*hr/mL/mg | Geometric Coefficient of Variation 25 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | 493.5 ug*hr/mL/mg | Geometric Coefficient of Variation 10 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | 541.9 ug*hr/mL/mg | Geometric Coefficient of Variation 8 |
| Cohort 5: PF-06755347 1 mg/kg IV | Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | 569.7 ug*hr/mL/mg | Geometric Coefficient of Variation 29 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | NA ug*hr/mL/mg | — |
Secondary
Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose
AUClast(dn) = AUClast/Dose
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 139.5 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 70 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 349.8 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 30 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 451.8 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 9 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 521.1 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 7 |
| Cohort 5: PF-06755347 1 mg/kg IV | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 511.8 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 29 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 451.8 ug*hr/mL/(mg/kg) | Geometric Coefficient of Variation 3 |
Secondary
Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose
Cmax(dn) = Cmax/Dose
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 11.23 ug/mL/(miligrams/kilogram [mg/kg]) | Geometric Coefficient of Variation 18 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 14.88 ug/mL/(miligrams/kilogram [mg/kg]) | Geometric Coefficient of Variation 20 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 16.54 ug/mL/(miligrams/kilogram [mg/kg]) | Geometric Coefficient of Variation 10 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 15.69 ug/mL/(miligrams/kilogram [mg/kg]) | Geometric Coefficient of Variation 9 |
| Cohort 5: PF-06755347 1 mg/kg IV | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 24.72 ug/mL/(miligrams/kilogram [mg/kg]) | Geometric Coefficient of Variation 21 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 17.68 ug/mL/(miligrams/kilogram [mg/kg]) | Geometric Coefficient of Variation 9 |
Secondary
Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose
Cmax was the highest concentration observed directly from data
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 0.1123 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 18 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 0.4462 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 20 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 1.654 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 10 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 4.700 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 9 |
| Cohort 5: PF-06755347 1 mg/kg IV | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 24.72 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 21 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 12.36 micrograms/milliliter (ug/mL) | Geometric Coefficient of Variation 9 |
Secondary
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1.
Time frame: Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts
Population: All participants who received at least 1 dose of study medication. Number of participants analyzed represents the total number of participants in each treatment group in the analysis population for this outcome measure. Number analyzed represents the number of participants who had reportable results for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 1 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 1: PF-06755347 0.01 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 5: PF-06755347 1 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 7: PF-06755347 25 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 1 Participants |
| Cohort 8: PF-06755347 50 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 1 Participants |
| Cohort 9: PF-06755347 100 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 10: PF-06755347 200 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 0 Participants |
| Cohort 11: PF-06755347 300 mg SC | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 0 Participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 15 positive ADA | 2 Participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 36 positive ADA | 2 Participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 8 positive ADA | 1 Participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Baseline postive ADA | 3 Participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibody to PF-06755347 | Day 71 positive ADA | 1 Participants |
Secondary
t½ of PF-06755347 Following Single SC Dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least one dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | t½ of PF-06755347 Following Single SC Dose | 94.13 hours | Standard Deviation 32.843 |
| Cohort 2: PF-06755347 0.03 mg/kg IV | t½ of PF-06755347 Following Single SC Dose | 135.6 hours | Standard Deviation 56.409 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | t½ of PF-06755347 Following Single SC Dose | 82.88 hours | Standard Deviation 19.498 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | t½ of PF-06755347 Following Single SC Dose | 100.1 hours | Standard Deviation 18.94 |
| Cohort 5: PF-06755347 1 mg/kg IV | t½ of PF-06755347 Following Single SC Dose | 139.3 hours | Standard Deviation 9.8658 |
Secondary
Terminal Half-life (t½) of PF-06755347 Following Single IV Dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least one dose and had at least 1 of the PK parameters of interest. All randomized participants who received at least one dose and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 2: PF-06755347 0.03 mg/kg IV | Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | 34.20 hours | Standard Deviation 7.3082 |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | 51.10 hours | Standard Deviation 4.7624 |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | 77.17 hours | Standard Deviation 0.40415 |
| Cohort 5: PF-06755347 1 mg/kg IV | Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | 70.90 hours | Standard Deviation 12.15 |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | NA hours | — |
Secondary
Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 1.270 hours |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 1.050 hours |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 1.180 hours |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 1.180 hours |
| Cohort 5: PF-06755347 1 mg/kg IV | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 1.170 hours |
| Cohort 6: PF-06755347 0.7 mg/kg IV | Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 3.020 hours |
Secondary
Tmax of PF-06755347 Following Single SC Dose
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Population: All randomized participants who received at least 1 dose of PF-06755347 and had at least 1 of the PK parameters of interest. No results were reported for 16 participants who received placebo because participants didn't receive the investigational product and had no PK parameter of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | Tmax of PF-06755347 Following Single SC Dose | 48.00 hours |
| Cohort 2: PF-06755347 0.03 mg/kg IV | Tmax of PF-06755347 Following Single SC Dose | 48.00 hours |
| Cohort 3: PF-06755347 0.1 mg/kg IV | Tmax of PF-06755347 Following Single SC Dose | 60.05 hours |
| Cohort 4: PF-06755347 0.3 mg/kg IV | Tmax of PF-06755347 Following Single SC Dose | 48.00 hours |
| Cohort 5: PF-06755347 1 mg/kg IV | Tmax of PF-06755347 Following Single SC Dose | 72.00 hours |