Severe Hemophilia
Conditions
Brief summary
This Phase 1 study will be a single-arm, open-label, non-randomized, non-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086 in Chinese adult participants with severe hemophilia.
Interventions
BIOLOGICALPF-06741086
single dose SC injection of 300 mg PF-06741086
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be male and 18 to \<75 years of age with a minimum body weight of 30 kg at screening. * Participants with a diagnosis of severe hemophilia A or B (FVIII or FIX activity \<1%, respectively) * Participants without inhibitor must also meet the following criteria: * No detectable or documented history of inhibitors * Participants with on-demand treatment regimen with ≥6 acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 4 months period prior to enrollment and willing to continue to receive on demand treatment during the study. * Participants with Inhibitor must also meet the following criteria: * Documentation of current high titer inhibitor (≥5 BU/mL) or current low titer inhibitor (\<5 BU/mL) refractory to FVIII or FIX replacement and with FVIII or FIX recovery \<60% of expected within previous 4 months prior to screening. * Participants with on-demand treatment regimen with ≥6 bleeding episodes (spontaneous and/or traumatic) necessitating treatment with bypass factor for at least 4 months prior to screening and willing to continue to receive on-demand treatment during the study.
Exclusion criteria
* Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis or ischemic disease * Known planned surgical procedure during the planned study period. * Known hemostatic defect other than hemophilia A or B. * Abnormal renal or hepatic function * Current unstable liver or biliary disease * Abnormal hematologic parameters * Abnormal coagulation activity * Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator. * Corrected QT interval (QTc) \>450 msec for male participants or QTc \>480 msec in participants with bundle branch block. * Individuals with hypersensitivity or an allergic reaction to hamster protein or other components of the study intervention. * A positive urine drug screen * Current routine prophylaxis with bypassing agent or non coagulation factor-replacement therapy (eg, emicizumab) * Regular, concomitant therapy with immunomodulatory drugs * Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study. * Participation in other studies involving investigational drug(s) within 30 days (or as determined by local requirements) or 5 half-lives prior to study entry and/or during study participation. * CD4 cell count ≤200/uL if human immunodeficiency virus (HIV)-positive * Baseline ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. * Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Injection Site Reactions | Day 1 to Day 7 | Grades of injection site reactions were defined according to NCI CTCAE version 5.0. Grade 1=Tenderness with or without associated symptoms (eg, warmth, erythema, itching); Grade 2= Pain, lipodystrophy, edema, phlebitis; Grade 3= Ulceration or necrosis, severe tissue damage, operative intervention indicated; Grade 4=Life-threatening consequences, urgent intervention indicated; Grade 5=death. Participants with any grade of injection site reaction are reported in this outcome measure. |
| Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR. |
| Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the WHO using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR. |
| Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | The 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 samples were obtained to evaluate APTT. |
| Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | The 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 samples were obtained to evaluate APTT. |
| Mean Absolute Value of Fibrinogen | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | 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. |
| Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | 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. |
| Mean Absolute Value of Antithrombin III (ATIII) | Day 1, Day 2, Day 7, Day 14, Day 21, Day 28 | ATIII is a nonvitamin K-dependent protease that inhibits coagulation by lysing thrombin and factor Xa. The antithrombin activity test measures how well the protein inhibits thrombin, with a reference range of 75% - 125%. Blood samples were obtained to evaluate ATIII activity. |
| Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28 | ATIII is a nonvitamin K-dependent protease that inhibits coagulation by lysing thrombin and factor Xa. The antithrombin activity test measures how well the protein inhibits thrombin, with a reference range of 75% - 125%. Blood samples were obtained to evaluate ATIII activity. |
| Mean Absolute Value of Cardiac Troponin I (cTnI) | Day 1, Day 2, Day 4 | cTnI is one of the cardiac regulatory proteins that control the calcium mediated interaction between actin and myosin, and is considered a specific marker for cardiac damage. Blood samples were obtained to evaluate the amount of cTnI. |
| Change From Baseline in cTnI at Days 2 and 4 | Baseline (Day 1), Day 2, Day 4 | cTnI is one of the cardiac regulatory proteins that control the calcium mediated interaction between actin and myosin, and is considered a specific marker for cardiac damage. Blood samples were obtained to evaluate the amount of cTnI. |
| Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Day 1 to Day 28 | Vital signs measurements included blood pressure (BP), pulse rate, respiratory rate and oral temperature. Categorical classes for vital signs of potential clinical concern included: (1) systolic BP - minimum (min) value \<90 mmHg, maximum (max) decrease/increase from baseline \>=30 mmHg; (2) diastolic BP - min value \<50 mmHg, max decrease/increase from baseline \>=20 mmHg; (3) supine pulse rate - min \<40 beat per minute (bpm) or max \>120 bpm; (4) standing pulse rate - min \<40 bpm or max \>140 bpm; (5) oral temperature \> 38.5 celsius degree (°C). BPs were measured in a supine position so standing BPs were not evaluated and not reported. |
| Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | BPs were assessed in a supine position with a completely automated device. Categorical classes for supine systolic BP of potential clinical concern included min value \<90 mmHg, max decrease/increase from baseline \>=30 mmHg. |
| Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | BPs were assessed in a supine position with a completely automated device. Categorical classes for supine diastolic BP of potential clinical concern included min value \<50 mmHg, max decrease/increase from baseline \>=20 mmHg. |
| Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Pulse rates were assessed in a supine position with a completely automated device. Categorical classes for supine pulse rate of potential clinical concern included min value \<40 bpm or max value \>120 bpm. |
| Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | No eating, drinking, or smoking was allowed for 15 minutes prior to the measurement of oral temperature. The criterion for oral temperature of potential clinical concern was oral temperature \> 38.5°C. |
| Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Respiratory rate measurement was preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Respiratory rate was measured in terms of breaths per minute, and was measured by observing and counting the respirations of the participant for 30 seconds and multiplied by 2. |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | Day 1 to Day 28 | Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS and QT intervals. If a single time point ECG was abnormal, a triplicate ECG was required and obtained approximately 2-4 minutes apart; the average of triplicate ECG measurements collected at pre-dose Day 1 served as each participant's baseline value. Categorical classes for ECG data of potential clinical concern included: (1) QTcF - 450 millisecond (msec)≤ max value \<480 msec, 480 msec ≤ max value \<500 msec, max value ≥500 msec; 30 msec ≤ QTcF max increase from baseline \<60 msec; max increase from baseline ≥60 msec; (2) PR interval - max value ≥300 msec, baseline value\>200 and max increase from baseline ≥25%, baseline value ≤200 and max increase from baseline ≥50%; (3) QRS interval - max value ≥140 msec, increase from baseline ≥50%. |
| Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Heart rate was measured in terms of beats per minute. Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. If a single time point ECG was abnormal, a triplicate ECG was required, which were obtained approximately 2-4 minutes apart; the average of the triplicate ECG measurements collected at pre-dose Day 1 served as each participant's baseline value. |
| Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. Categorical classes for PR interval data of potential clinical concern included: max value ≥300 ms, baseline value\>200 and max increase from baseline≥25%, baseline value ≤200 and max increase from baseline ≥50%. |
| Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. Categorical classes for QRS interval data of potential clinical concern included: max value ≥140 ms, increase from baseline ≥50%. |
| Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. |
| Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. The corrected QT interval (QTc) estimates the QT interval at a standard heart rate of 60 bpm. |
| Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28. | Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. QTcF = QT interval corrected using the Fridericia method. Categorical classes for QTcF data of potential clinical concern included: 450 ms≤ max value \<480 ms, 480≤ max value \<500 ms, max value ≥500 ms; 30 ms ≤ QTcF max increase from baseline \<60 ms; max increase from baseline ≥60 ms. |
| Number of Participants With Physical Examination Findings | Screening (Day -35 to Day -2), Day -1, Day 1 (for general appearance, heart, lungs), Day 7 (for general appearance, heart, lungs), Day 28 (for general appearance, heart, lungs) | A complete PE included assessments of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. A brief PE included assessments of the general appearance, the respiratory and cardiovascular systems, as well as participant reported symptoms. The full PE planned for Screening may have been performed on Day -1 before dosing at the discretion of the Investigator. If a full PE was done at Screening visit, a brief PE was to be conducted on Day-1. After Day -1, brief examinations based on signs and symptoms may have been performed if clinically indicated at the discretion of the Investigator to assess changes from baseline/previous visits of any ongoing symptoms. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 1 to Day 42 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed at baseline. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL);Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=events with life-threatening consequences, urgent intervention indicated;Grade 5= death related to AE.Treatment-related TEAEs were determined by investigator. |
| Number of Participants With Serious Adverse Events (SAEs) | Day 1 to Day 42 | An 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 disability/incapacity; was a congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator. |
| Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs | Day 1 to Day 42 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator. |
| Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study | Day 1 to Day 42 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator. |
| Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Day 1 to Day 28 | Laboratory assessments included chemistry, hematology, Prothrombin Time/International Normalized Ratio (PT/INR), Activated Partial Thromboplastin Time (APTT), urinalysis, fibrinogen, Antithrombin III (ATIII) activity, and Cardiac Troponin I (cTnI). Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure. ULN = upper limit of normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Maximum plasma concentration of marstacimab after participants received a single SC injection of marstacimab 300 mg. |
| Time for Cmax (Tmax) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Time for Cmax of marstacimab after participants received a single SC injection of marstacimab 300 mg. |
| Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration of marstacimab after participants received a single SC injection of marstacimab 300 mg. |
| Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Area under the concentration time curve from time zero to infinity of marstacimab after participants received a single SC injection of marstacimab 300 mg. |
| Terminal Half-Life (t1/2) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Terminal half life (t1/2) of marstacimab after participants received a single SC injection of marstacimab 300 mg. t1/2 is defined as the time for plasma concentration to decrease by one half. |
| Apparent Volume of Distribution (Vz/F) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Apparent volume of distribution of marstacimab after participants received a single SC injection of marstacimab 300 mg. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was influenced by the fraction absorbed. Vz/F was calculated as dose/AUCinf. AUCinf = area under the concentration time curve from time zero to infinity. |
| Apparent Clearance (CL/F) of Marstacimab | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Apparent clearance (CL/F) of marstacimab after participants received a single SC injection of marstacimab 300 mg. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as Dose/ (AUCinf\*kel). AUCinf = area under the concentration time curve from time zero to infinity. kel = terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. |
| Maximum Increase From Baseline for Tissue Factor Pathway Inhibitor (TFPI), Day 1 up to Day 28 | Day 1 to Day 28 | TFPI is a protease inhibitor, which acts as an antagonist of the extrinsic coagulation pathway via inhibition of tissue factor-activated coagulation factor VII (FVIIa) and activated factor X (FXa). Plasma total TFPI levels were measured to reflect target binding with marstacimab. TFPI in results represented total TFPI. |
| Area Under the Curve (AUC) of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TFPI | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in TFPI at specific time points. Area under the TFPI change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. TFPI represented total TFPI. |
| Maximum Increase From Baseline for Prothrombin Fragments 1+2 (PF 1+2), Day 1 up to Day 28 | Day 1 to Day 28 | PF1+2 is an in vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for PF 1+2 was provided. |
| AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for PF 1+2 | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in PF 1+2 at specific time points. Area under the PF 1+2 change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. |
| Maximum Increase From Baseline for D-Dimer, Day 1 up to Day 28 | Day 1 to Day 28 | D-dimer is an in vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for D-Dimer is provided. |
| AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for D-Dimer | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in D-dimer at specific time points. Area under the D-dimer change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. |
| Maximum Decrease From Baseline for Dilute Prothrombin Time (dPT), Day 1 up to Day 28 | Day 1 to Day 28 | The dilute prothrombin time (dPT) is an ex vivo endpoint reflective of coagulation pathway activation. Maximum decrease from baseline for dPT is provided. |
| AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for dPT | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in dPT at specific time points. Area under the dPT change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. |
| Maximum Decrease From Baseline for Thrombin Generation Assay (TGA) Lag Time, Day 1 up to Day 28 | Day 1 to Day 28 | TGA lag time is an ex vivo endpoint reflective of coagulation pathway activation. Maximum decrease from baseline for TGA Lag Time is provided. |
| AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Lag Time | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in TGA lag time at specific time points. Area under the TGA lag time change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. |
| Maximum Increase From Baseline for TGA Peak, Day 1 up to Day 28 | Day 1 to Day 28 | TGA peak is an ex vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for TGA Peak is provided. |
| AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Peak | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in TGA peak at specific time points. Area under the TGA peak change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. |
| Maximum Increase From Baseline for TGA Endogenous Thrombin Potential (EGTP), Day 1 up to Day 28 | Day 1 to Day 28 | TGA EGTP is an ex vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for TGA Endogenous Thrombin Potential is provided. |
| AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA EGTP | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | A change from baseline-time profile was established based on changes from baseline in TGA EGTP at specific time points. Area under the TGA EGTP change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. |
| Number of Participants With Anti-Drug Antibody (ADA) Against Marstacimab | Day 1 pre-dose (-2 hours to -5 min prior to dosing); Day 14; Day 21; Day 28 | Summary of ADA incidence by visit is presented. ADA positive was defined as titer \>=1.54. |
| Number of Participants With Neutralizing Antibody (NAb) Against Marstacimab | Day 1 pre-dose (-2 hours to -5 min prior to dosing); Day 14; Day 21; Day 28 | Summary of NAb incidence by visit is presented. NAb positive was defined as titer \>=1.08. ADA-positive participants (defined as titer \>=1.54) were analyzed for NAb. |
| Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing | Mean plasma concentration of marstacimab after participants received a single SC injection of marstacimab 300 mg. |
Countries
China
Participant flow
Pre-assignment details
A total of 6 participants were enrolled and received a single dose of marstacimab 300 mg.
Participants by arm
| Arm | Count |
|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose Participants received a single SC injection of marstacimab 300 mg on Study Day 1. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose |
|---|---|
| Age, Continuous | 31.5 years |
| Age, Customized 18-64 years | 6 Participants |
| Age, Customized <18 years | 0 Participants |
| Age, Customized >=65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Chinese | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants |
| Race/Ethnicity, Customized Other (Not Chinese) | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change From Baseline in APTT at Days 2, 7, 14, 21 and 28
The 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 samples were obtained to evaluate APTT.
Time frame: Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Day 2 | 1.77 Second | Standard Deviation 6.431 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Day 7 | 2.40 Second | Standard Deviation 7.294 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Day 14 | -4.43 Second | Standard Deviation 16.987 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Day 21 | -21.28 Second | Standard Deviation 16.632 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in APTT at Days 2, 7, 14, 21 and 28 | Day 28 | -16.47 Second | Standard Deviation 13.733 |
Primary
Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28
ATIII is a nonvitamin K-dependent protease that inhibits coagulation by lysing thrombin and factor Xa. The antithrombin activity test measures how well the protein inhibits thrombin, with a reference range of 75% - 125%. Blood samples were obtained to evaluate ATIII activity.
Time frame: Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Day 2 | -4.07 percent of antithrombin III activity | Standard Deviation 4.399 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Day 7 | 1.32 percent of antithrombin III activity | Standard Deviation 5.739 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Day 14 | 5.23 percent of antithrombin III activity | Standard Deviation 7.655 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Day 21 | 3.35 percent of antithrombin III activity | Standard Deviation 5.899 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ATIII at Days 2, 7, 14, 21 and 28 | Day 28 | 4.43 percent of antithrombin III activity | Standard Deviation 6.207 |
Primary
Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28
Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. QTcF = QT interval corrected using the Fridericia method. Categorical classes for QTcF data of potential clinical concern included: 450 ms≤ max value \<480 ms, 480≤ max value \<500 ms, max value ≥500 ms; 30 ms ≤ QTcF max increase from baseline \<60 ms; max increase from baseline ≥60 ms.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -11.38 millisecond | Standard Deviation 9.55 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -5.38 millisecond | Standard Deviation 8.692 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -3.22 millisecond | Standard Deviation 7.499 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | -8.55 millisecond | Standard Deviation 12.561 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -2.88 millisecond | Standard Deviation 10.471 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | 0.28 millisecond | Standard Deviation 8.084 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -4.88 millisecond | Standard Deviation 12.496 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -7.05 millisecond | Standard Deviation 7.9 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -10.88 millisecond | Standard Deviation 11.337 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | -5.55 millisecond | Standard Deviation 9.932 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | -15.22 millisecond | Standard Deviation 11.354 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Corrected QT Interval (Fridericia Method) (QTcF Interval) at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | -11.05 millisecond | Standard Deviation 12.049 |
Primary
Change From Baseline in cTnI at Days 2 and 4
cTnI is one of the cardiac regulatory proteins that control the calcium mediated interaction between actin and myosin, and is considered a specific marker for cardiac damage. Blood samples were obtained to evaluate the amount of cTnI.
Time frame: Baseline (Day 1), Day 2, Day 4
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention. Number of Participants Analyzed = Number of participants evaluable for this outcome measure. Number Analyzed = number of participants evaluable at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in cTnI at Days 2 and 4 | Day 2 | 0.0000 ng/mL | Standard Deviation 0 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in cTnI at Days 2 and 4 | Day 4 | 0.0000 ng/mL | Standard Deviation 0 |
Primary
Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28
BPs were assessed in a supine position with a completely automated device. Categorical classes for supine diastolic BP of potential clinical concern included min value \<50 mmHg, max decrease/increase from baseline \>=20 mmHg.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -2.67 mmHg | Standard Deviation 7.659 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -3.83 mmHg | Standard Deviation 7.91 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | -6.33 mmHg | Standard Deviation 7.146 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -8.67 mmHg | Standard Deviation 6.653 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | -3.50 mmHg | Standard Deviation 8.597 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -5.17 mmHg | Standard Deviation 6.145 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -4.83 mmHg | Standard Deviation 8.085 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -5.17 mmHg | Standard Deviation 6.145 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | -4.17 mmHg | Standard Deviation 9.087 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | 5.83 mmHg | Standard Deviation 9.475 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | -1.50 mmHg | Standard Deviation 8.118 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Diastolic Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -0.33 mmHg | Standard Deviation 6.218 |
Primary
Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28
Heart rate was measured in terms of beats per minute. Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. If a single time point ECG was abnormal, a triplicate ECG was required, which were obtained approximately 2-4 minutes apart; the average of the triplicate ECG measurements collected at pre-dose Day 1 served as each participant's baseline value.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -1.73 beats per minute | Standard Deviation 8.899 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | 0.43 beats per minute | Standard Deviation 8.514 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -1.57 beats per minute | Standard Deviation 8.105 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | 1.43 beats per minute | Standard Deviation 14.581 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | -1.57 beats per minute | Standard Deviation 4.67 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -3.07 beats per minute | Standard Deviation 9.917 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -3.90 beats per minute | Standard Deviation 11.858 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -5.73 beats per minute | Standard Deviation 10.56 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | 0.60 beats per minute | Standard Deviation 17.58 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | 9.43 beats per minute | Standard Deviation 10.869 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | 3.60 beats per minute | Standard Deviation 5.953 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in ECG Mean Heart Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | 4.43 beats per minute | Standard Deviation 10.872 |
Primary
Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28
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.
Time frame: Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Day 2 | -17.3 mg/dL | Standard Deviation 26.82 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Day 7 | -34.8 mg/dL | Standard Deviation 27.02 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Day 14 | -0.3 mg/dL | Standard Deviation 39.73 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Day 21 | -16.7 mg/dL | Standard Deviation 39.33 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Fibrinogen at Days 2, 7, 14, 21 and 28 | Day 28 | -11.2 mg/dL | Standard Deviation 74.66 |
Primary
Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28
No eating, drinking, or smoking was allowed for 15 minutes prior to the measurement of oral temperature. The criterion for oral temperature of potential clinical concern was oral temperature \> 38.5°C.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | 0.10 degree Celsius | Standard Deviation 0.502 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | 0.28 degree Celsius | Standard Deviation 0.621 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | 0.50 degree Celsius | Standard Deviation 0.827 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | 0.17 degree Celsius | Standard Deviation 0.501 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | 0.22 degree Celsius | Standard Deviation 0.581 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | 0.25 degree Celsius | Standard Deviation 0.582 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | 0.10 degree Celsius | Standard Deviation 0.566 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -0.08 degree Celsius | Standard Deviation 0.523 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | 0.30 degree Celsius | Standard Deviation 0.626 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | 0.45 degree Celsius | Standard Deviation 0.701 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | 0.67 degree Celsius | Standard Deviation 0.7 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Oral Temperature at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | 0.75 degree Celsius | Standard Deviation 0.579 |
Primary
Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28
Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. Categorical classes for PR interval data of potential clinical concern included: max value ≥300 ms, baseline value\>200 and max increase from baseline≥25%, baseline value ≤200 and max increase from baseline ≥50%.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -4.22 millisecond | Standard Deviation 12.49 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | 0.45 millisecond | Standard Deviation 33.789 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | -8.38 millisecond | Standard Deviation 20.696 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -6.55 millisecond | Standard Deviation 9.592 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | -10.88 millisecond | Standard Deviation 8.697 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -2.72 millisecond | Standard Deviation 7.236 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -6.05 millisecond | Standard Deviation 11.031 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -4.55 millisecond | Standard Deviation 8.547 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | -6.22 millisecond | Standard Deviation 19.135 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | -10.22 millisecond | Standard Deviation 12.921 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | -8.05 millisecond | Standard Deviation 13.602 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PR Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -4.05 millisecond | Standard Deviation 23.21 |
Primary
Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28
PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the WHO using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR.
Time frame: Baseline (Day 1), Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Day 2 | -0.010 Ratio | Standard Deviation 0.0363 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Day 7 | -0.028 Ratio | Standard Deviation 0.0611 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Day 14 | -0.040 Ratio | Standard Deviation 0.0379 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Day 21 | -0.018 Ratio | Standard Deviation 0.0492 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in PT/INR at Days 2, 7, 14, 21 and 28 | Day 28 | -0.012 Ratio | Standard Deviation 0.0741 |
Primary
Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28
Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. Categorical classes for QRS interval data of potential clinical concern included: max value ≥140 ms, increase from baseline ≥50%.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -2.27 millisecond | Standard Deviation 4.698 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -4.27 millisecond | Standard Deviation 6.953 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | -2.27 millisecond | Standard Deviation 5.972 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -1.60 millisecond | Standard Deviation 4.459 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | 1.57 millisecond | Standard Deviation 5.315 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -2.77 millisecond | Standard Deviation 7.64 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -2.60 millisecond | Standard Deviation 5.713 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -4.10 millisecond | Standard Deviation 5.968 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | -0.43 millisecond | Standard Deviation 4.855 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | -5.10 millisecond | Standard Deviation 5.312 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | -4.60 millisecond | Standard Deviation 5.646 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QRS Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -4.60 millisecond | Standard Deviation 7.505 |
Primary
Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28
Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -6.57 millisecond | Standard Deviation 14.714 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -0.90 millisecond | Standard Deviation 16.16 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | -11.07 millisecond | Standard Deviation 24.048 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -0.07 millisecond | Standard Deviation 21.771 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | 2.60 millisecond | Standard Deviation 8.63 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | 0.77 millisecond | Standard Deviation 20.963 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | 0.60 millisecond | Standard Deviation 17.506 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -0.07 millisecond | Standard Deviation 28.348 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | -5.90 millisecond | Standard Deviation 29.938 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | -30.40 millisecond | Standard Deviation 21.731 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | -17.57 millisecond | Standard Deviation 18.007 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -19.07 millisecond | Standard Deviation 23.601 |
Primary
Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28
Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. The corrected QT interval (QTc) estimates the QT interval at a standard heart rate of 60 bpm.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -4.15 millisecond | Standard Deviation 14.416 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -4.82 millisecond | Standard Deviation 11.811 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | -7.15 millisecond | Standard Deviation 22.601 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -4.15 millisecond | Standard Deviation 11.556 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | -0.32 millisecond | Standard Deviation 11.397 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -7.82 millisecond | Standard Deviation 16.104 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -11.65 millisecond | Standard Deviation 17.928 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -16.82 millisecond | Standard Deviation 8.169 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | -4.98 millisecond | Standard Deviation 22.013 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | -8.48 millisecond | Standard Deviation 15.359 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | -8.98 millisecond | Standard Deviation 12.716 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in QT Interval Corrected at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -8.65 millisecond | Standard Deviation 11.854 |
Primary
Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28
Respiratory rate measurement was preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Respiratory rate was measured in terms of breaths per minute, and was measured by observing and counting the respirations of the participant for 30 seconds and multiplied by 2.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -1.67 breaths per minute | Standard Deviation 1.751 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -0.50 breaths per minute | Standard Deviation 1.049 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -0.67 breaths per minute | Standard Deviation 1.033 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | 0.17 breaths per minute | Standard Deviation 2.994 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -0.50 breaths per minute | Standard Deviation 3.209 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | -1.50 breaths per minute | Standard Deviation 1.975 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -1.33 breaths per minute | Standard Deviation 1.506 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -1.67 breaths per minute | Standard Deviation 3.502 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | 1.00 breaths per minute | Standard Deviation 4.98 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | 3.50 breaths per minute | Standard Deviation 2.811 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | 3.83 breaths per minute | Standard Deviation 3.312 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Respiratory Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | 2.67 breaths per minute | Standard Deviation 3.141 |
Primary
Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28
Pulse rates were assessed in a supine position with a completely automated device. Categorical classes for supine pulse rate of potential clinical concern included min value \<40 bpm or max value \>120 bpm.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | -1.33 bpm | Standard Deviation 3.011 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | -2.00 bpm | Standard Deviation 3.521 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | 0.33 bpm | Standard Deviation 11.003 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -1.50 bpm | Standard Deviation 11.537 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | -5.33 bpm | Standard Deviation 6.501 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -6.67 bpm | Standard Deviation 8.937 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | -7.33 bpm | Standard Deviation 6.683 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | -4.33 bpm | Standard Deviation 11.361 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | 0.17 bpm | Standard Deviation 15.198 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | 14.33 bpm | Standard Deviation 12.209 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | 15.50 bpm | Standard Deviation 13.882 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Pulse Rate at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | 10.50 bpm | Standard Deviation 12.74 |
Primary
Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28
BPs were assessed in a supine position with a completely automated device. Categorical classes for supine systolic BP of potential clinical concern included min value \<90 mmHg, max decrease/increase from baseline \>=30 mmHg.
Time frame: Day 1 pre-dose (baseline); 1 hour, 2 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing; Day 2; Day 3; Day 4; Day 7; Day 14; Day 21; Day 28.
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | 2.50 mmHg | Standard Deviation 9.503 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 2 hours post Day 1 dosing | 1.67 mmHg | Standard Deviation 8.189 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | 4.17 mmHg | Standard Deviation 8.519 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 8 hours post Day 1 dosing | -1.83 mmHg | Standard Deviation 5.981 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | 3.00 mmHg | Standard Deviation 9.274 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2 | -0.67 mmHg | Standard Deviation 6.346 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3 | 0.17 mmHg | Standard Deviation 8.183 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4 | 2.17 mmHg | Standard Deviation 4.446 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7 | 1.67 mmHg | Standard Deviation 10.053 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14 | 4.00 mmHg | Standard Deviation 7.563 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21 | 1.00 mmHg | Standard Deviation 8.854 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Change From Baseline in Supine Systolic BP at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28 | -0.50 mmHg | Standard Deviation 13.019 |
Primary
Mean Absolute Value of Activated Partial Thromboplastin Time (APTT)
The 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 samples were obtained to evaluate APTT.
Time frame: Day 1, Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 7 | 87.78 second | Standard Deviation 14.376 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 14 | 80.95 second | Standard Deviation 17.521 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 1 | 85.38 second | Standard Deviation 14.377 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 2 | 87.15 second | Standard Deviation 15.473 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 21 | 64.10 second | Standard Deviation 21.833 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Activated Partial Thromboplastin Time (APTT) | Day 28 | 68.92 second | Standard Deviation 16.144 |
Primary
Mean Absolute Value of Antithrombin III (ATIII)
ATIII is a nonvitamin K-dependent protease that inhibits coagulation by lysing thrombin and factor Xa. The antithrombin activity test measures how well the protein inhibits thrombin, with a reference range of 75% - 125%. Blood samples were obtained to evaluate ATIII activity.
Time frame: Day 1, Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Antithrombin III (ATIII) | Day 1 | 92.75 percent of antithrombin III activity | Standard Deviation 6.498 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Antithrombin III (ATIII) | Day 2 | 88.68 percent of antithrombin III activity | Standard Deviation 3.939 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Antithrombin III (ATIII) | Day 7 | 94.07 percent of antithrombin III activity | Standard Deviation 4.384 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Antithrombin III (ATIII) | Day 14 | 97.98 percent of antithrombin III activity | Standard Deviation 6.386 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Antithrombin III (ATIII) | Day 21 | 96.10 percent of antithrombin III activity | Standard Deviation 3.949 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Antithrombin III (ATIII) | Day 28 | 97.18 percent of antithrombin III activity | Standard Deviation 7.885 |
Primary
Mean Absolute Value of Cardiac Troponin I (cTnI)
cTnI is one of the cardiac regulatory proteins that control the calcium mediated interaction between actin and myosin, and is considered a specific marker for cardiac damage. Blood samples were obtained to evaluate the amount of cTnI.
Time frame: Day 1, Day 2, Day 4
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention. Number of Participants Analyzed = Number of participants evaluable for this outcome measure. Number Analyzed = number of participants evaluable at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Cardiac Troponin I (cTnI) | Day 1 | 0.0250 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Cardiac Troponin I (cTnI) | Day 2 | 0.0250 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Cardiac Troponin I (cTnI) | Day 4 | 0.0250 nanogram per milliliter (ng/mL) | Standard Deviation 0 |
Primary
Mean Absolute Value of Fibrinogen
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.
Time frame: Day 1, Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Fibrinogen | Day 28 | 273.2 milligram per deciliter (mg/dL) | Standard Deviation 43.73 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Fibrinogen | Day 1 | 284.3 milligram per deciliter (mg/dL) | Standard Deviation 61.68 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Fibrinogen | Day 2 | 267.0 milligram per deciliter (mg/dL) | Standard Deviation 52.37 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Fibrinogen | Day 7 | 249.5 milligram per deciliter (mg/dL) | Standard Deviation 72.82 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Fibrinogen | Day 14 | 284.0 milligram per deciliter (mg/dL) | Standard Deviation 50.12 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Fibrinogen | Day 21 | 267.7 milligram per deciliter (mg/dL) | Standard Deviation 30.18 |
Primary
Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR)
PT is one of the laboratory tests to evaluate the ability of blood clotting. The INR is derived from PT which is calculated as a ratio of a participant's PT to a control PT standardized for the potency of the thromboplastin reagent developed by the World Health Organization (WHO) using the following formula: INR = Participant PT / Control PT. Blood samples were obtained to evaluate PT/INR.
Time frame: Day 1, Day 2, Day 7, Day 14, Day 21, Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 1 | 1.000 ratio | Standard Deviation 0.079 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 2 | 0.990 ratio | Standard Deviation 0.0632 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 7 | 0.972 ratio | Standard Deviation 0.0549 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 14 | 0.960 ratio | Standard Deviation 0.069 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 21 | 0.982 ratio | Standard Deviation 0.0902 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Absolute Value of Prothrombin Time (PT) / International Normalized Ratio (INR) | Day 28 | 0.988 ratio | Standard Deviation 0.092 |
Primary
Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern
Single 12-lead ECGs were performed for all participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS and QT intervals. If a single time point ECG was abnormal, a triplicate ECG was required and obtained approximately 2-4 minutes apart; the average of triplicate ECG measurements collected at pre-dose Day 1 served as each participant's baseline value. Categorical classes for ECG data of potential clinical concern included: (1) QTcF - 450 millisecond (msec)≤ max value \<480 msec, 480 msec ≤ max value \<500 msec, max value ≥500 msec; 30 msec ≤ QTcF max increase from baseline \<60 msec; max increase from baseline ≥60 msec; (2) PR interval - max value ≥300 msec, baseline value\>200 and max increase from baseline ≥25%, baseline value ≤200 and max increase from baseline ≥50%; (3) QRS interval - max value ≥140 msec, increase from baseline ≥50%.
Time frame: Day 1 to Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | PR Interval Value >=300 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | PR Interval >=25% increase when baseline PR>200 msec, >=50% increase when baseline PR <=200 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QRS Interval value >=140 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QRS Interval % change from baseline >=50% | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QT Interval value >500 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QTcF Interval value >= 450 msec and <480 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QTcF Interval value >= 480 msec and <500 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QTcF Interval value >= 500 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QTcF Interval change from baseline >=30 msec and <60 msec | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria of Potential Clinical Concern | QTcF Interval change from baseline >=60 msec | 0 Participants |
Primary
Number of Participants With Injection Site Reactions
Grades of injection site reactions were defined according to NCI CTCAE version 5.0. Grade 1=Tenderness with or without associated symptoms (eg, warmth, erythema, itching); Grade 2= Pain, lipodystrophy, edema, phlebitis; Grade 3= Ulceration or necrosis, severe tissue damage, operative intervention indicated; Grade 4=Life-threatening consequences, urgent intervention indicated; Grade 5=death. Participants with any grade of injection site reaction are reported in this outcome measure.
Time frame: Day 1 to Day 7
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Injection Site Reactions | 0 Participants |
Primary
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
Laboratory assessments included chemistry, hematology, Prothrombin Time/International Normalized Ratio (PT/INR), Activated Partial Thromboplastin Time (APTT), urinalysis, fibrinogen, Antithrombin III (ATIII) activity, and Cardiac Troponin I (cTnI). Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure. ULN = upper limit of normal.
Time frame: Day 1 to Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | APTT >1.1 x ULN | 6 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Urine hemoglobin >=1 | 1 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality | Urobilinogen >=1 | 2 Participants |
Primary
Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator.
Time frame: Day 1 to Day 42
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Maximum Grade 3 or 4 or 5 TEAEs | 0 Participants |
Primary
Number of Participants With Physical Examination Findings
A complete PE included assessments of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. A brief PE included assessments of the general appearance, the respiratory and cardiovascular systems, as well as participant reported symptoms. The full PE planned for Screening may have been performed on Day -1 before dosing at the discretion of the Investigator. If a full PE was done at Screening visit, a brief PE was to be conducted on Day-1. After Day -1, brief examinations based on signs and symptoms may have been performed if clinically indicated at the discretion of the Investigator to assess changes from baseline/previous visits of any ongoing symptoms.
Time frame: Screening (Day -35 to Day -2), Day -1, Day 1 (for general appearance, heart, lungs), Day 7 (for general appearance, heart, lungs), Day 28 (for general appearance, heart, lungs)
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Ears at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Ears on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Eyes at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Eyes on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Gastrointestinal at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Gastrointestinal on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | General appearance at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | General appearance on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | General appearance on Day 1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | General appearance on Day 7 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | General appearance on Day 28 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Head at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Head on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Heart at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Heart on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Heart on Day 1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Heart on Day 7 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Heart on Day 28 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lungs at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lungs on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lungs on Day 1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lungs on Day 7 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lungs on Day 28 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lymph nodes at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Lymph nodes on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Mouth at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Mouth on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Musculoskeletal system at screening | 6 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Musculoskeletal system on Day -1 | 6 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Neurological system at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Neurological system on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Nose at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Nose on Day -1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Skin at screening | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Physical Examination Findings | Skin on Day -1 | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
An 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 disability/incapacity; was a congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Time frame: Day 1 to Day 42
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. Grades of AEs were defined by NCI CTCAE version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator.
Time frame: Day 1 to Day 42
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With TEAEs Leading to Permanent or Temporary Discontinuation From Study | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs that started during the effective duration of treatment regardless of whether a similar event existed at baseline. Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL);Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=events with life-threatening consequences, urgent intervention indicated;Grade 5= death related to AE.Treatment-related TEAEs were determined by investigator.
Time frame: Day 1 to Day 42
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | All-Causality TEAEs | 1 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Treatment-Related TEAEs | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | All-Causality Severe TEAEs | 0 Participants |
Primary
Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern
Vital signs measurements included blood pressure (BP), pulse rate, respiratory rate and oral temperature. Categorical classes for vital signs of potential clinical concern included: (1) systolic BP - minimum (min) value \<90 mmHg, maximum (max) decrease/increase from baseline \>=30 mmHg; (2) diastolic BP - min value \<50 mmHg, max decrease/increase from baseline \>=20 mmHg; (3) supine pulse rate - min \<40 beat per minute (bpm) or max \>120 bpm; (4) standing pulse rate - min \<40 bpm or max \>140 bpm; (5) oral temperature \> 38.5 celsius degree (°C). BPs were measured in a supine position so standing BPs were not evaluated and not reported.
Time frame: Day 1 to Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine systolic BP value <90 mmHg | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine systolic BP increase from baseline >=30 mmHg | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine systolic BP decrease from baseline >=30 mmHg | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine diastolic BP value <50 mmHg | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine diastolic BP increase from baseline >=20 mmHg | 1 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine diastolic BP decrease from baseline >=20 mmHg | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine pulse rate value <40 bpm | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Supine pulse rate value >120 bpm | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Vital Signs Data Meeting Categorical Criteria of Potential Clinical Concern | Body temperature >38.5 °C | 0 Participants |
Secondary
Apparent Clearance (CL/F) of Marstacimab
Apparent clearance (CL/F) of marstacimab after participants received a single SC injection of marstacimab 300 mg. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as Dose/ (AUCinf\*kel). AUCinf = area under the concentration time curve from time zero to infinity. kel = terminal phase rate constant calculated by a linear regression of the log linear concentration time curve.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters. Number of Participants Analyzed = number of participants contributing to the summary statistics for this outcome measure
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Apparent Clearance (CL/F) of Marstacimab | 0.06595 Liter per hour | Geometric Coefficient of Variation 7 |
Secondary
Apparent Volume of Distribution (Vz/F) of Marstacimab
Apparent volume of distribution of marstacimab after participants received a single SC injection of marstacimab 300 mg. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was influenced by the fraction absorbed. Vz/F was calculated as dose/AUCinf. AUCinf = area under the concentration time curve from time zero to infinity.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters. Number of Participants Analyzed = number of participants contributing to the summary statistics for this outcome measure
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Apparent Volume of Distribution (Vz/F) of Marstacimab | 8.305 Liter | Geometric Coefficient of Variation 29 |
Secondary
Area Under the Curve (AUC) of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TFPI
A change from baseline-time profile was established based on changes from baseline in TFPI at specific time points. Area under the TFPI change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure. TFPI represented total TFPI.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Area Under the Curve (AUC) of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TFPI | AUC of change from baseline values Days 1-7 for TFPI | 5730.07 ng*hr/mL | Standard Deviation 2891.283 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Area Under the Curve (AUC) of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TFPI | AUC of change from baseline values Days 1-14 for TFPI | 15425.73 ng*hr/mL | Standard Deviation 9469.364 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Area Under the Curve (AUC) of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TFPI | AUC of change from baseline values Days 1-28 for TFPI | 15526.33 ng*hr/mL | Standard Deviation 14100.382 |
Secondary
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of Marstacimab
Area under the concentration time curve from time zero to infinity of marstacimab after participants received a single SC injection of marstacimab 300 mg.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters. Number of Participants Analyzed = number of participants contributing to the summary statistics for this outcome measure
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of Marstacimab | 4549000 ng*hr/mL | Geometric Coefficient of Variation 7 |
Secondary
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Marstacimab
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration of marstacimab after participants received a single SC injection of marstacimab 300 mg.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Marstacimab | 2917000 nanogram * hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 60 |
Secondary
AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for D-Dimer
A change from baseline-time profile was established based on changes from baseline in D-dimer at specific time points. Area under the D-dimer change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for D-Dimer | AUC of change from baseline values Days 1-7 for D-dimer | 46.245 microgram * hour/milliliter (µg*hr/mL) | Standard Deviation 29.3806 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for D-Dimer | AUC of change from baseline values Days 1-14 for D-dimer | 110.855 microgram * hour/milliliter (µg*hr/mL) | Standard Deviation 71.0567 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for D-Dimer | AUC of change from baseline values Days 1-28 for D-dimer | 176.463 microgram * hour/milliliter (µg*hr/mL) | Standard Deviation 153.1565 |
Secondary
AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for dPT
A change from baseline-time profile was established based on changes from baseline in dPT at specific time points. Area under the dPT change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for dPT | AUC of change from baseline values Days 1-7 for dPT | -1910.10 second * hour (sec*hr) | Standard Deviation 1800.853 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for dPT | AUC of change from baseline values Days 1-14 for dPT | -4079.87 second * hour (sec*hr) | Standard Deviation 4094.644 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for dPT | AUC of change from baseline values Days 1-28 for dPT | -6792.18 second * hour (sec*hr) | Standard Deviation 7068.384 |
Secondary
AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for PF 1+2
A change from baseline-time profile was established based on changes from baseline in PF 1+2 at specific time points. Area under the PF 1+2 change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for PF 1+2 | AUC of change from baseline values Days 1-7 for PF 1+2 | 56871.2823 picomole * hour/liter (pmol*hr/L) | Standard Deviation 17578.69955 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for PF 1+2 | AUC of change from baseline values Days 1-14 for PF 1+2 | 116439.2948 picomole * hour/liter (pmol*hr/L) | Standard Deviation 38634.76646 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for PF 1+2 | AUC of change from baseline values Days 1-28 for PF 1+2 | 144733.7020 picomole * hour/liter (pmol*hr/L) | Standard Deviation 49783.6715 |
Secondary
AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA EGTP
A change from baseline-time profile was established based on changes from baseline in TGA EGTP at specific time points. Area under the TGA EGTP change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA EGTP | AUC of change from baseline values Days 1-7 for TGA EGTP | 123700.0 nanomole * minute * hour (nmol*min*hr) | Standard Deviation 35312.5 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA EGTP | AUC of change from baseline values Days 1-14 for TGA EGTP | 238797.8 nanomole * minute * hour (nmol*min*hr) | Standard Deviation 47387.58 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA EGTP | AUC of change from baseline values Days 1-28 for TGA EGTP | 332461.2 nanomole * minute * hour (nmol*min*hr) | Standard Deviation 69573.95 |
Secondary
AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Lag Time
A change from baseline-time profile was established based on changes from baseline in TGA lag time at specific time points. Area under the TGA lag time change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Lag Time | AUC of change from baseline values Days 1-7 for TGA lag time | -95.10 minute * hour (min*hr) | Standard Deviation 37.787 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Lag Time | AUC of change from baseline values Days 1-14 for TGA lag time | -188.08 minute * hour (min*hr) | Standard Deviation 81.227 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Lag Time | AUC of change from baseline values Days 1-28 for TGA lag time | -174.70 minute * hour (min*hr) | Standard Deviation 234.641 |
Secondary
AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Peak
A change from baseline-time profile was established based on changes from baseline in TGA peak at specific time points. Area under the TGA peak change from baseline-time profile from time zero (Day 1) to Day 7, from time zero to Day 14 and from time zero to Day 28 are presented in this outcome measure.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Peak | AUC of change from baseline values Days 1-7 for TGA peak | 10584.58 nanomole * hour (nmol*hr) | Standard Deviation 3169.434 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Peak | AUC of change from baseline values Days 1-14 for TGA peak | 20276.98 nanomole * hour (nmol*hr) | Standard Deviation 5557.219 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | AUC of Change From Baseline Values (Days 1-7, Days 1-14, Days 1-28) for TGA Peak | AUC of change from baseline values Days 1-28 for TGA peak | 28016.08 nanomole * hour (nmol*hr) | Standard Deviation 9062.199 |
Secondary
Maximum Decrease From Baseline for Dilute Prothrombin Time (dPT), Day 1 up to Day 28
The dilute prothrombin time (dPT) is an ex vivo endpoint reflective of coagulation pathway activation. Maximum decrease from baseline for dPT is provided.
Time frame: Day 1 to Day 28
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Decrease From Baseline for Dilute Prothrombin Time (dPT), Day 1 up to Day 28 | -19.62 second | Standard Deviation 13.079 |
Secondary
Maximum Decrease From Baseline for Thrombin Generation Assay (TGA) Lag Time, Day 1 up to Day 28
TGA lag time is an ex vivo endpoint reflective of coagulation pathway activation. Maximum decrease from baseline for TGA Lag Time is provided.
Time frame: Day 1 to Day 28
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Decrease From Baseline for Thrombin Generation Assay (TGA) Lag Time, Day 1 up to Day 28 | -0.92 minute | Standard Deviation 0.279 |
Secondary
Maximum Increase From Baseline for D-Dimer, Day 1 up to Day 28
D-dimer is an in vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for D-Dimer is provided.
Time frame: Day 1 to Day 28
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Increase From Baseline for D-Dimer, Day 1 up to Day 28 | 0.463 microgram per milliliter (µg/mL) | Standard Deviation 0.2881 |
Secondary
Maximum Increase From Baseline for Prothrombin Fragments 1+2 (PF 1+2), Day 1 up to Day 28
PF1+2 is an in vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for PF 1+2 was provided.
Time frame: Day 1 to Day 28
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Increase From Baseline for Prothrombin Fragments 1+2 (PF 1+2), Day 1 up to Day 28 | 531.9 picomole per liter (pmol/L) | Standard Deviation 126.91 |
Secondary
Maximum Increase From Baseline for TGA Endogenous Thrombin Potential (EGTP), Day 1 up to Day 28
TGA EGTP is an ex vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for TGA Endogenous Thrombin Potential is provided.
Time frame: Day 1 to Day 28
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Increase From Baseline for TGA Endogenous Thrombin Potential (EGTP), Day 1 up to Day 28 | 1093.7 nanomole * minute (nmol*min) | Standard Deviation 332.76 |
Secondary
Maximum Increase From Baseline for TGA Peak, Day 1 up to Day 28
TGA peak is an ex vivo endpoint reflective of coagulation pathway activation. Maximum increase from baseline for TGA Peak is provided.
Time frame: Day 1 to Day 28
Population: All participants treated who had at least 1 of the PD parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Increase From Baseline for TGA Peak, Day 1 up to Day 28 | 105.83 nanomole (nmol) | Standard Deviation 13.124 |
Secondary
Maximum Increase From Baseline for Tissue Factor Pathway Inhibitor (TFPI), Day 1 up to Day 28
TFPI is a protease inhibitor, which acts as an antagonist of the extrinsic coagulation pathway via inhibition of tissue factor-activated coagulation factor VII (FVIIa) and activated factor X (FXa). Plasma total TFPI levels were measured to reflect target binding with marstacimab. TFPI in results represented total TFPI.
Time frame: Day 1 to Day 28
Population: The analysis population included all participants treated who had at least 1 of the pharmacodynamic (PD) parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Increase From Baseline for Tissue Factor Pathway Inhibitor (TFPI), Day 1 up to Day 28 | 79.50 ng/mL | Standard Deviation 36.374 |
Secondary
Maximum Plasma Concentration (Cmax) of Marstacimab
Maximum plasma concentration of marstacimab after participants received a single SC injection of marstacimab 300 mg.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Maximum Plasma Concentration (Cmax) of Marstacimab | 15610 ng/mL | Geometric Coefficient of Variation 35 |
Secondary
Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28
Mean plasma concentration of marstacimab after participants received a single SC injection of marstacimab 300 mg.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all participants treated who had at least 1 marstacimab concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 1 pre-dose | 0.0000 ng/mL | Standard Deviation 0 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 1 hour post Day 1 dosing | 582.0 ng/mL | Standard Deviation 1313.2 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 4 hours post Day 1 dosing | 1746 ng/mL | Standard Deviation 960.3 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | 12 hours post Day 1 dosing | 5647 ng/mL | Standard Deviation 2254.2 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 2, 24 hours post Day 1 dosing | 9033 ng/mL | Standard Deviation 3349.8 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 3, 48 hours post Day 1 dosing | 14300 ng/mL | Standard Deviation 5510.3 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 4, 72 hours post Day 1 dosing | 16060 ng/mL | Standard Deviation 5706.9 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 7, approximately 144 hours post Day 1 dosing | 14600 ng/mL | Standard Deviation 4693.9 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 14, approximately 312 hours post Day 1 dosing | 3437 ng/mL | Standard Deviation 2349.3 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 21, approximately 480 hours post Day 1 dosing | 53.17 ng/mL | Standard Deviation 130.23 |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Mean Plasma Marstacimab Concentration Versus Time at Days 1, 2, 3, 4, 7, 14, 21 and 28 | Day 28, approximately 648 hours post Day 1 dosing | 0.0000 ng/mL | Standard Deviation 0 |
Secondary
Number of Participants With Anti-Drug Antibody (ADA) Against Marstacimab
Summary of ADA incidence by visit is presented. ADA positive was defined as titer \>=1.54.
Time frame: Day 1 pre-dose (-2 hours to -5 min prior to dosing); Day 14; Day 21; Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Anti-Drug Antibody (ADA) Against Marstacimab | Day 1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Anti-Drug Antibody (ADA) Against Marstacimab | Day 14 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Anti-Drug Antibody (ADA) Against Marstacimab | Day 21 | 1 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Anti-Drug Antibody (ADA) Against Marstacimab | Day 28 | 1 Participants |
Secondary
Number of Participants With Neutralizing Antibody (NAb) Against Marstacimab
Summary of NAb incidence by visit is presented. NAb positive was defined as titer \>=1.08. ADA-positive participants (defined as titer \>=1.54) were analyzed for NAb.
Time frame: Day 1 pre-dose (-2 hours to -5 min prior to dosing); Day 14; Day 21; Day 28
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention. Number of Participants Analyzed = the total number of participants who had ADA-positive results in this study. Number Analyzed = Number of participants who had ADA-positive results at the specific time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Neutralizing Antibody (NAb) Against Marstacimab | Day 1 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Neutralizing Antibody (NAb) Against Marstacimab | Day 14 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Neutralizing Antibody (NAb) Against Marstacimab | Day 21 | 0 Participants |
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Number of Participants With Neutralizing Antibody (NAb) Against Marstacimab | Day 28 | 0 Participants |
Secondary
Terminal Half-Life (t1/2) of Marstacimab
Terminal half life (t1/2) of marstacimab after participants received a single SC injection of marstacimab 300 mg. t1/2 is defined as the time for plasma concentration to decrease by one half.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters. Number of Participants Analyzed = number of participants contributing to the summary statistics for this outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Terminal Half-Life (t1/2) of Marstacimab | 90.48 hour | Standard Deviation 26.025 |
Secondary
Time for Cmax (Tmax) of Marstacimab
Time for Cmax of marstacimab after participants received a single SC injection of marstacimab 300 mg.
Time frame: Pre-dose, and 1 hour, 4 hours, 12 hours, 24 hours, 48 hours, 72 hours, and approximately 144 hours, 312 hours, 480 hours and 648 hours post Day 1 dosing
Population: The analysis population included all enrolled participants who received at least 1 dose of study intervention and had at least 1 of the PK parameters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06741086 (Marstacimab) 300 mg Subcutaneous (SC) Single Dose | Time for Cmax (Tmax) of Marstacimab | 73.15 hour |