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This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spray-dried S/D-treated plasma | Experimental | Resusix (Spray-Dried Solvent/Detergent-Treated Plasma) uses source plasma from U.S.-licensed facilities as the starting material. Source plasma donors are selected from the AB blood type, which is considered a "universal" product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spray-dried S/D-treated Plasma | Biological | Infusion of 100 mL Spray-dried S/D-treated Plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent SAEs | Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of select coagulation factors | To evaluate the recovery of select coagulation factors after infusion of 2 Resusix | 30 minutes post infusion |
| Incidence of AEs | To evaluate the incidence of AEs for up to 12 weeks after infusion of Resusix |
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Inclusion Criteria:
Subject must provide written informed consent for participation in this study and valid contact information.
Subject must be a male or postmenopausal female.
Subject must be at least 18 years of age and not older than 55 years of age.
Subject must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, including no history or symptoms of respiratory or cardiac disease.
Vital signs should be within normal limits at Screening:
Subject must have a normal (no clinically significant abnormality) EKG at Screening and prior to administration of Resusix
Subject must have laboratory hematology values within following normal ranges:
Subject must have laboratory clinical chemistry values within normal range specified by the testing laboratory.
BMI ≤30 kg/m2.
Subject must have a negative toxicology screening panel (urine test including qualitative identification of PCP, barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine.)
Subject must be a non-drinker (≤2 alcoholic beverages per week) and a non-smoker (any tobacco products within six months prior to Screening).
Subject must have no history of recreational (including IV) drug use (by self-declaration).
Subject must have the ability and willingness to attend frequent visits to the study center.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Vince, DO | Vince & Associates Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
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| Spray-dried S/D-treated plasma | Drug | Infusion of 200mL Spray-dried S/D-treated plasma |
|
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| Spray-dried S/D-treated Plasma | Biological | Infusion of 500 mL Spray-dried S/D-treated plasma |
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| Spray-dried S/D-treated Plasma | Biological | Infusion of 750 mL Spray-dried S/D-treated Plasma |
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| Spray-dried S/D-treated Plasma | Biological | Infusion of 800 mL Spray-dried S/D-treated Plasma |
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| 12 weeks |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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