A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA

Number of Participants Discontinued From Study Due to TEAEs

时间窗: Study Day 1 to Day 113 Visit

An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.

Number of Participants With Abnormal Laboratory Findings-Hematology

时间窗: Baseline to Study Day 113 Visit

Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Predefined criteria for hemoglobin and hematocrit: \<0.8\*lower limit of normal (LLN) or \<0.8\*Baseline(Baseline \<1.0\*LLN); for platelets: \<100,000\*10\^3/mm\^3 or \<= 0.77\*Baseline (Baseline \<1.0\*LLN).

Change From Baseline for Fibrinogen by Dose Cohort

时间窗: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.

Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen.

Number of Participants With Infusion and Injection Site Reactions

时间窗: Baseline to Study Day 113 Visit

Infusion and injection site reactions included: injection site bruising, injection site erythema, injection site haemorrhage, injection site induration, injection site pain, injection site pruritus, injection site swelling and injection site warmth. Grade of severity was defined as follows: Mild: Transient or mild discomfort (\< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible.

Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry

时间窗: Baseline to Study Day 113

Clinical chemistry evaluation included bilirubin, direct and indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, troponin I, cholesterol and fibrinogen.

Number of Participants With Abnormal Laboratory Findings-Urinalysis

时间窗: Baseline to Study Day 113 Visit

Urinalysis included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes and bacteria.

Change From Baseline for Antithrombin III by Dose Cohort

时间窗: Baseline, Study Day 8, 15, 22 and 29.

Antithrombin (AT) is a protein produced by the liver that helps regulate blood clot formation (i.e., a naturally-occurring mild blood thinner). Blood samples were collected to measure the activity (function) and the amount (quantity) of antithrombin in an individual's blood is used to evaluate the person for excessive blood clotting.

Change From Baseline for Troponin I by Dose Cohort

时间窗: Baseline, Study Day 8, 15, 22, 29, 57 and 85.

Blood samples were collected to measure the level of cardiac-specific troponin I in the blood to help detect heart injury.

Number of Participants With Vital Signs Data Meeting Pre-specified Criteria

时间窗: Baseline to Study Day 113 Visit

Criteria for potentially clinically important findings in vital signs data were defined as: 1) supine systolic blood pressure (BP): value \<90 mm Hg or change \>=30 mm Hg increase; 2) Supine diastolic BP: value \<50 mm Hg or change \>=20 mm Hg increase; 3) Supine pulse rate: value \<40 beats/min or \>120 beats/min.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

时间窗: Study Day 1 to Day 113 Visit

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator.

Change From Baseline for Globulin by Dose Cohort

时间窗: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.

Blood samples were obtained to determine globulin level in serum, total globulin was derived as total protein other than albumin.

Number of Participants With Electrocardiogram (ECG) Change Meeting Pre-specified Criteria

时间窗: Baseline to Study Day 29 Visit.

Criteria for potentially clinically important changes in ECG were defined as: PR interval baseline \>200 msec and increase of \>=25%; PR interval baseline \<=200 msec and increase of \>=50%; QRS interval increase of \>=50%. Only the number of participants meeting pre-defined criteria was reported below.

Number of Participants With Clinically Significant Changes in Physical Examination Findings

时间窗: Baseline to Study Day 113 Visit

Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.

Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort

时间窗: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.

Blood samples were obtained to evaluate this ratio. The prothrombin time (PT) is a test that helps evaluate your ability to appropriately form blood clots. The international normalized ratio (INR) is a calculation based on results of a PT that is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin (Coumadin®).

Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort

时间窗: Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.

The activated partial thromboplastin time (aPTT) is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood sample were obtained to evaluate aPTT.