Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Coagulation Defects
• Intervention / Treatment: Biological: Spray-dried S/D-treated Plasma; Drug: Spray-dried S/D-treated plasma; Biological: Spray-dried S/D-treated Plasma; Biological: Spray-dried S/D-treated Plasma; Biological: Spray-dried S/D-treated Plasma

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince & Associates Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject must provide written informed consent for participation in this study and valid contact information.
2. Subject must be a male or postmenopausal female.
3. Subject must be at least 18 years of age and not older than 55 years of age.
4. 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.

5. Vital signs should be within normal limits at Screening:

   1. Body temperature within 97°F to 99°F
   2. Heart rate 45 to 100 beats per minute (bpm)
   3. Systolic blood pressure (SBP) within 90 to 140 mmHg and DBP within 50 to 90 mmHg.

6. Subject must have a normal (no clinically significant abnormality) EKG at Screening and prior to administration of Resusix

   1. PR interval within 120 and 200 mm/s
   2. QRS interval <120 mm/s
   3. QTc interval ≤440 mm/s

7. Subject must have laboratory hematology values within following normal ranges:

   1. White blood cell count (WBC): 4,500 to 11,000/mL
   2. Platelet (PLT) count: 150,000 to 400,000/mL;
   3. Hemoglobin (Hb): 12.5 to 15.5 g/dL;
   4. Activated partial thromboplastin time (aPTT): 24.6 to 36.7 seconds;
   5. Normal PT, International Normalized Ratio (INR): 0.8 to 1.2;
   6. Protein C ≥90%, Protein S ≥77%;
   7. Antithrombin III levels (ATIII) ≥100%.
8. Subject must have laboratory clinical chemistry values within normal range specified by the testing laboratory.
9. BMI ≤30 kg/m2.
10. Subject must have a negative toxicology screening panel (urine test including qualitative identification of PCP, barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine.)
11. Subject must be a non-drinker (≤2 alcoholic beverages per week) and a non-smoker (any tobacco products within six months prior to Screening).
12. Subject must have no history of recreational (including IV) drug use (by self-declaration).
13. Subject must have the ability and willingness to attend frequent visits to the study center.

Exclusion Criteria:

1. Subject with lower extremity deep vein thrombosis (DVT) at Screening.
2. Subject has a history of coagulopathy or thromboembolic disease.
3. Subject has a first degree family member with history of venous thromboembolic disease <55 years of age or arterial thromboembolic disease <45 years of age.
4. Subject has documented drug allergies with well-described reactions.
5. Subject has hepatomegaly, splenomegaly, adenopathy, bruising, and/or ecchymoses identified at Screening.
6. Subject is found to have positive NAT test for HIV, HBV or HCV.
7. Subject has any murmurs, rubs, or gallops on cardiac auscultation.
8. Subject has had a previous transfusion at any time.
9. Subject is unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Spray-dried S/D-treated plasma; 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.

Biological: Spray-dried S/D-treated Plasma; Infusion of 100 mL Spray-dried S/D-treated Plasma; Other Names: Resusix; Drug: Spray-dried S/D-treated plasma; Infusion of 200mL Spray-dried S/D-treated plasma; Other Names: Resusix; Biological: Spray-dried S/D-treated Plasma; Infusion of 500 mL Spray-dried S/D-treated plasma; Other Names: Resusix; Biological: Spray-dried S/D-treated Plasma; Infusion of 750 mL Spray-dried S/D-treated Plasma; Other Names: Resusix; Biological: Spray-dried S/D-treated Plasma; Infusion of 800 mL Spray-dried S/D-treated Plasma; Other Names: Resusix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	12 weeks

Collaborators and Investigators

• Sponsor: Entegrion, Inc.
• Investigators: Principal Investigator: Bradley Vince, DO, Vince & Associates Clinical Research, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): September 9, 2016
• Study Completion (Actual): September 9, 2016

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: April 30, 2012
• First Posted (Estimate): May 2, 2012

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Hemorrhage; Transfusion; Resuscitation; Fresh Frozen Plasma; Coagulopathy; Entegrion; Spray-dried Solvent/Detergent Plasma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: RSX-102