A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

• PF-06755347 intravenous healthy participant (Drug): Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
• Placebo intravenous healthy participant (Drug): Placebo comparator
• PF-06755347 subcutaneous healthy participant (Drug): single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
• Placebo subcutaneous healthy participant (Drug): placebo comparator
• PF-06755347 subcutaneous ITP (Drug): single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants

Primary outcomes

• 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 outcomes

• 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
• 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
• 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
• 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.
• 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.

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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).

Exclusion Criteria for ITP participants

* History of clinically significant hematological (other than ITP), renal, endocrine, metabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Chest X-ray with evidence of current, active TB, previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities.

Chest x-ray must be taken at Screening or within 3 months prior to Screening and read by a qualified radiologist.

* Any bleeding event requiring medical evaluation or treatment in the 4 weeks prior to screening or current bleeding event that requires treatment.
* Scheduled or anticipated invasive procedures (eg, surgery, dental procedures) within 28 days following PF-06755347 dosing.
* Splenectomy within ≤180 days prior to PF-06755347 dosing or splenectomy planned during the period of the study.
* History of any active autoimmune disorder (other than ITP) or other conditions that may compromise or impair the immune system (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Graves' disease, and asthma).
* History of allergic or anaphylactic reaction to any drug including immunoglobulin.
* History of active infections within 28 days prior to the screening visit.
* History of Hepatitis B, Hepatitis C or HIV or current positive results for any of the following serological tests - HBsAg, HBcAb, HCVAb or HIV.
* History of thromboembolic events
* Hemoglobin <9 g/dL.
* Positive Direct Coombs test

Participant flow

Outcome results

• Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs (Primary), Count of participants, Participants: Cohort 1: PF-06755347 0.01 mg/kg IV 3; Cohort 2: PF-06755347 0.03 mg/kg IV 2; Cohort 3: PF-06755347 0.1 mg/kg IV 3; Cohort 4: PF-06755347 0.3 mg/kg IV 3; Cohort 5: PF-06755347 1 mg/kg IV 3; Cohort 6: PF-06755347 0.7 mg/kg IV 3; Cohort 7: PF-06755347 25 mg SC 3; Cohort 8: PF-06755347 50 mg SC 6; Cohort 9: PF-06755347 100 mg SC 6; Cohort 10: PF-06755347 200 mg SC 5; Cohort 11: PF-06755347 300 mg SC 3; Placebo 10
• Number of Participants With Laboratory Test Abnormalities (Primary), Count of participants, Participants: Cohort 1: PF-06755347 0.01 mg/kg IV 0; Cohort 2: PF-06755347 0.03 mg/kg IV 0; Cohort 3: PF-06755347 0.1 mg/kg IV 0; Cohort 4: PF-06755347 0.3 mg/kg IV 1; Cohort 5: PF-06755347 1 mg/kg IV 1; Cohort 6: PF-06755347 0.7 mg/kg IV 0; Cohort 7: PF-06755347 25 mg SC 0; Cohort 8: PF-06755347 50 mg SC 0; Cohort 9: PF-06755347 100 mg SC 1; Cohort 10: PF-06755347 200 mg SC 0; Cohort 11: PF-06755347 300 mg SC 0; Placebo 3
• Number of Participants With Vital Signs Meeting Categorical Criteria (Primary), Count of participants, Participants: Cohort 1: PF-06755347 0.01 mg/kg IV 0; Cohort 2: PF-06755347 0.03 mg/kg IV 0; Cohort 3: PF-06755347 0.1 mg/kg IV 0; Cohort 4: PF-06755347 0.3 mg/kg IV 0; Cohort 5: PF-06755347 1 mg/kg IV 0; Cohort 6: PF-06755347 0.7 mg/kg IV 0; Cohort 7: PF-06755347 25 mg SC 0; Cohort 8: PF-06755347 50 mg SC 0; Cohort 9: PF-06755347 100 mg SC 6; Cohort 10: PF-06755347 200 mg SC 5; Cohort 11: PF-06755347 300 mg SC 3; Placebo 0
• Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria (Primary), Count of participants, Participants: Cohort 1: PF-06755347 0.01 mg/kg IV 0; Cohort 2: PF-06755347 0.03 mg/kg IV 0; Cohort 3: PF-06755347 0.1 mg/kg IV 0; Cohort 4: PF-06755347 0.3 mg/kg IV 0; Cohort 5: PF-06755347 1 mg/kg IV 0; Cohort 6: PF-06755347 0.7 mg/kg IV 0; Cohort 7: PF-06755347 25 mg SC 0; Cohort 8: PF-06755347 50 mg SC 0; Cohort 9: PF-06755347 100 mg SC 0; Cohort 10: PF-06755347 200 mg SC 0; Cohort 11: PF-06755347 300 mg SC 0; Placebo 0
• Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose (Secondary), Geometric mean, micrograms/milliliter (ug/mL): Cohort 1: PF-06755347 0.01 mg/kg IV 0.1123 +/- 18; Cohort 2: PF-06755347 0.03 mg/kg IV 0.4462 +/- 20; Cohort 3: PF-06755347 0.1 mg/kg IV 1.654 +/- 10; Cohort 4: PF-06755347 0.3 mg/kg IV 4.700 +/- 9; Cohort 5: PF-06755347 1 mg/kg IV 24.72 +/- 21; Cohort 6: PF-06755347 0.7 mg/kg IV 12.36 +/- 9
• Cmax of PF-06755347 Following Single SC Dose (Secondary), Geometric mean, ug/mL: Cohort 7: PF-06755347 25 mg SC 0.8946 +/- 25; Cohort 8: PF-06755347 50 mg SC 1.374 +/- 68; Cohort 9: PF-06755347 100 mg SC 2.641 +/- 40; Cohort 10: PF-06755347 200 mg SC 5.678 +/- 15; Cohort 11: PF-06755347 300 mg SC 5.276 +/- 47
• Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose (Secondary), Geometric mean, ug/mL/(miligrams/kilogram [mg/kg]): Cohort 1: PF-06755347 0.01 mg/kg IV 11.23 +/- 18; Cohort 2: PF-06755347 0.03 mg/kg IV 14.88 +/- 20; Cohort 3: PF-06755347 0.1 mg/kg IV 16.54 +/- 10; Cohort 4: PF-06755347 0.3 mg/kg IV 15.69 +/- 9; Cohort 5: PF-06755347 1 mg/kg IV 24.72 +/- 21; Cohort 6: PF-06755347 0.7 mg/kg IV 17.68 +/- 9
• Cmax(dn) of PF-06755347 Following Single SC Dose (Secondary), Geometric mean, ug/mL/(mg/kg): Cohort 7: PF-06755347 25 mg SC 0.03579 +/- 25; Cohort 8: PF-06755347 50 mg SC 0.02748 +/- 68; Cohort 9: PF-06755347 100 mg SC 0.02641 +/- 40; Cohort 10: PF-06755347 200 mg SC 0.02842 +/- 15; Cohort 11: PF-06755347 300 mg SC 5.276 +/- 0.01758
• Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose (Secondary), Median, hours: Cohort 1: PF-06755347 0.01 mg/kg IV 1.270 (1.22 to 1.30); Cohort 2: PF-06755347 0.03 mg/kg IV 1.050 (1.05 to 1.08); Cohort 3: PF-06755347 0.1 mg/kg IV 1.180 (1.17 to 1.18); Cohort 4: PF-06755347 0.3 mg/kg IV 1.180 (1.18 to 1.18); Cohort 5: PF-06755347 1 mg/kg IV 1.170 (1.17 to 3.30); Cohort 6: PF-06755347 0.7 mg/kg IV 3.020 (1.00 to 3.03)
• Tmax of PF-06755347 Following Single SC Dose (Secondary), Median, hours: Cohort 7: PF-06755347 25 mg SC 48.00 (48.00 to 72.00); Cohort 8: PF-06755347 50 mg SC 48.00 (48.00 to 48.90); Cohort 9: PF-06755347 100 mg SC 60.05 (48.00 to 96.00); Cohort 10: PF-06755347 200 mg SC 48.00 (24.00 to 96.00); Cohort 11: PF-06755347 300 mg SC 72.00 (48.00 to 120.00)
• 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 (Secondary), Geometric mean, micrograms*hour/milliliter (ug*hr/mL): Cohort 1: PF-06755347 0.01 mg/kg IV 1.395 +/- 70; Cohort 2: PF-06755347 0.03 mg/kg IV 10.51 +/- 30; Cohort 3: PF-06755347 0.1 mg/kg IV 45.18 +/- 9; Cohort 4: PF-06755347 0.3 mg/kg IV 156.4 +/- 7; Cohort 5: PF-06755347 1 mg/kg IV 511.8 +/- 29; Cohort 6: PF-06755347 0.7 mg/kg IV 316.2 +/- 3
• AUClast of PF-06755347 Following Single SC Dose (Secondary), Geometric mean, ug*hr/mL: Cohort 7: PF-06755347 25 mg SC 125.4 +/- 12; Cohort 8: PF-06755347 50 mg SC 230.2 +/- 42; Cohort 9: PF-06755347 100 mg SC 428.7 +/- 24; Cohort 10: PF-06755347 200 mg SC 859.5 +/- 13; Cohort 11: PF-06755347 300 mg SC 977.6 +/- 30
• Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose (Secondary), Geometric mean, ug*hr/mL/(mg/kg): Cohort 1: PF-06755347 0.01 mg/kg IV 139.5 +/- 70; Cohort 2: PF-06755347 0.03 mg/kg IV 349.8 +/- 30; Cohort 3: PF-06755347 0.1 mg/kg IV 451.8 +/- 9; Cohort 4: PF-06755347 0.3 mg/kg IV 521.1 +/- 7; Cohort 5: PF-06755347 1 mg/kg IV 511.8 +/- 29; Cohort 6: PF-06755347 0.7 mg/kg IV 451.8 +/- 3
• AUClast(dn) of PF-06755347 Following Single SC Dose (Secondary), Geometric mean, ug*hr/mL/(mg/kg): Cohort 7: PF-06755347 25 mg SC 5.010 +/- 13; Cohort 8: PF-06755347 50 mg SC 4.603 +/- 42; Cohort 9: PF-06755347 100 mg SC 4.287 +/- 24; Cohort 10: PF-06755347 200 mg SC 4.297 +/- 13; Cohort 11: PF-06755347 300 mg SC 3.263 +/- 30
• Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose (Secondary), Geometric mean, ug*hr/mL: Cohort 1: PF-06755347 0.01 mg/kg IV ; Cohort 2: PF-06755347 0.03 mg/kg IV 12.52 +/- 25; Cohort 3: PF-06755347 0.1 mg/kg IV 49.35 +/- 10; Cohort 4: PF-06755347 0.3 mg/kg IV 162.7 +/- 8; Cohort 5: PF-06755347 1 mg/kg IV 569.7 +/- 29; Cohort 6: PF-06755347 0.7 mg/kg IV NA +/- NA
• AUCinf of PF-06755347 Following Single SC Dose (Secondary), Geometric mean, ug*hr/mL: Cohort 7: PF-06755347 25 mg SC 133.2 +/- 10; Cohort 8: PF-06755347 50 mg SC 234.7 +/- 42; Cohort 9: PF-06755347 100 mg SC 440.1 +/- 25; Cohort 10: PF-06755347 200 mg SC 861.3 +/- 15; Cohort 11: PF-06755347 300 mg SC 988.8 +/- 30
• Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose (Secondary), Geometric mean, ug*hr/mL/mg: Cohort 1: PF-06755347 0.01 mg/kg IV ; Cohort 2: PF-06755347 0.03 mg/kg IV 417.5 +/- 25; Cohort 3: PF-06755347 0.1 mg/kg IV 493.5 +/- 10; Cohort 4: PF-06755347 0.3 mg/kg IV 541.9 +/- 8; Cohort 5: PF-06755347 1 mg/kg IV 569.7 +/- 29; Cohort 6: PF-06755347 0.7 mg/kg IV NA +/- NA
• AUCinf(dn) of PF-06755347 Following Single SC Dose (Secondary), Geometric mean, ug*hr/mL/mg: Cohort 7: PF-06755347 25 mg SC 5.323 +/- 11; Cohort 8: PF-06755347 50 mg SC 4.695 +/- 42; Cohort 9: PF-06755347 100 mg SC 4.401 +/- 25; Cohort 10: PF-06755347 200 mg SC 4.305 +/- 15; Cohort 11: PF-06755347 300 mg SC 3.295 +/- 30
• Terminal Half-life (t½) of PF-06755347 Following Single IV Dose (Secondary), Mean, hours: Cohort 1: PF-06755347 0.01 mg/kg IV ; Cohort 2: PF-06755347 0.03 mg/kg IV 34.20 +/- 7.3082; Cohort 3: PF-06755347 0.1 mg/kg IV 51.10 +/- 4.7624; Cohort 4: PF-06755347 0.3 mg/kg IV 77.17 +/- 0.40415; Cohort 5: PF-06755347 1 mg/kg IV 70.90 +/- 12.150; Cohort 6: PF-06755347 0.7 mg/kg IV NA +/- NA
• t½ of PF-06755347 Following Single SC Dose (Secondary), Mean, hours: Cohort 7: PF-06755347 25 mg SC 94.13 +/- 32.843; Cohort 8: PF-06755347 50 mg SC 135.6 +/- 56.409; Cohort 9: PF-06755347 100 mg SC 82.88 +/- 19.498; Cohort 10: PF-06755347 200 mg SC 100.1 +/- 18.940; Cohort 11: PF-06755347 300 mg SC 139.3 +/- 9.8658
• 9 more outcome measures not shown.

Adverse events

Time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).

Serious adverse events by term

Other adverse events by term

28 more terms not shown.

Limitations and caveats: The study was terminated due to sponsor's business decision.

• Study Protocol (PDF, 2022-07-25)
• Statistical Analysis Plan (PDF, 2017-07-10)

• Pfizer CT.gov Call Center, Study director, Pfizer

NIH grants: 2018