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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004369-38 | EudraCT Number |
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The study was terminated due to a change in the benefit/risk assessment for the further administration of marstacimab in a healthy volunteer population.
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The goal in this study is to show that there are not significant differences in biologic activity of the study drug when administered using either the prefilled pen and prefilled syringe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marstacimab Prefilled Pen (PFP), then marstacimab Preflled Syringe (PFS) | Experimental | Participants will first receive single dose PFP, then PFS, then repeating single dose PFP, then single dose PFS with a minimum of 21 days between single doses. |
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| Marstacimab PFS, then marstacimab PFP | Experimental | Participants will first receive single dose PFS, then PFP, then repeating single dose PFS, then single dose PFP with a minimum of 21 days between single doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marstacimab PFP | Drug | 300 milligrams (mg) subcutaneous injection marstacimab PFP |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the plasma concentraiton time Curve from time zero extrapolated to infinite time (AUCinf) | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose | |
| Maximum observed plasma concentration (Cmax) | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve from time 0 to time of last quatifiable concenteration | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose | |
| Time for Cmax | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose |
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Inclusion Criteria:
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease
Any condition possibly affecting drug absorption (eg, conditions affecting SC administration)
Previous or current treatment for and/or history of coronary artery diseases, venous or arterial thrombosis, or ischemic disease.
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality or COVID-19 related condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
A positive urine drug test at screening and/or admission
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)
Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Participants with ANY of the following abnormalities in clinical laboratory tests at screening:
An estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 based on the CKD-EPI equation.
Resistance to activated protein C (or Factor V Leiden mutation), prothrombin 20210 mutation, antithrombin III deficiency, protein C deficiency, or protein S deficiency.
Presence of Lupus anticoagulant anti-cardiolipin antibodies (IgG, IgM or IgA)
High sensitivity C-reactive protein (hsCRP) above the upper limits of normal
Abnormal hematology values as defined by the following laboratory tests at Screening and/or admission:
A positive COVID-19 test.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening
Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the protocol
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels Clinical Research Unit | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000656192 | marstacimab |
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| Marstacimab PFS | Drug | 300 mg subcutaneous injection of marstacimab PFS |
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| Apparent clearance after subcutaneous dose | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose |
| Apparent volume of distribution after subcutaneous dose | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose |
| Terminal half-life after subcutaneous dose | Day 1 Hour 0, 1, 2, 4, 8, 12, 24, 48, 72; Day 7; Day 14; Day 21 after each dose |
| Incidence of clinically significant laboratory value abnormalities | Baseline through the end of study, approximately 161 days |
| Incidence of anti-drug antibody against marstacimab | From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days |
| Incidence of Adverse Events | Baseline through the end of study, approximately 161 days |
| Incidence of neutralizing antibody against marstacimab | From Day 1, Period 1 through Day 21, Period 4 over a total of 84 days |
| Incidence of Serious Adverse Events | Baseline through the end of study, approximately 161 days |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |