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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001821-17 | EudraCT Number |
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This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo | Experimental |
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| Cohort 2 (SC) PF-06741086, Placebo | Experimental |
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| Cohort 3 (SC) PF-06741086, Placebo | Experimental |
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| Cohort 4 (Intravenous [IV]) PF-06741086, Placebo | Experimental |
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| Cohort 5 (IV) PF-06741086, Placebo | Experimental |
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| Cohort 6 (IV) PF-06741086, Placebo | Experimental |
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| Cohort 7 (IV) PF-06741086, Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06741086 | Biological | PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s) |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs | Day 1 up to Day 84 | |
| Percentage of subjects with laboratory abnormalities | Day 1 up to Day 84 | |
| Number of subjects with change from baseline in vital signs | blood pressure, pulse rate, temperature, respiration rate | Day 1 up to Day 84 |
| Number of subjects with change from baseline in electrocardiogram (ECG) parameters | Day 1 to Day 84 | |
| Percentage of subjects with changes from baseline in physical examination | Day 1 to Day 84 | |
| Percentage of subjects with infusion site reactions | Day 1 up to Day 7 | |
| Percentage of subjects with injection site reactions | Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PF-06741086 concentrations | Day 1 up to Day 84 | |
| Maximum observed plasma concentration (Cmax) | Day 1 up to Day 84 | |
| Time for Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | 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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| ID | Term |
|---|---|
| C000656192 | marstacimab |
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| Cohort 8 (subcutaneous [SC]) PF-06741086 | Experimental |
|
| Placebo | Drug | Placebo for PF-06741086, single dose |
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| Day 1 up to Day 84 |
| Area under the curve from time zero to last quantifiable concentration (AUClast) | Day 1 up to Day 84 |
| Terminal half-life (t 1/2) | Day 1 up to Day 84 |
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) | Day 1 up to Day 84 |
| Volume of distribution at steady state (Vss) | Intravenous administration only | Day 1 up to Day 84 |
| Apparent volume of distribution (Vz/F) | Subcutaneous administration only | Day 1 up to Day 84 |
| Clearance (CL) | Intravenous administration only | Day 1 up to Day 84 |
| Apparent clearance (CL/F) | Subcutaneous administration only | Day 1 up to Day 84 |
| Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)] | Day 1 up to Day 84 |
| Mean residence time (MRT) | Day 1 up to Day 84 |
| Total tissue factor pathway inhibitor concentrations over time | Day 1 up to Day 84 |
| Thrombin generation | may include lag time, peak thrombin generation, and endogenous thrombin generation potential | Day 1 up to Day 84 |
| Prothrombin fragment 1+2 (PF1+2) concentrations over time | Day 1 up to Day 84 |
| D-dimer concentrations over time | Day 1 up to Day 84 |
| Dilute prothrombin time (dPT) | Day 1 up to Day 84 |
| Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production | Immunogenicity | Day 1 up to Day 84 |