Overview

This trial is active, not recruiting.

Condition coagulation defects
Treatments spray-dried s/d-treated plasma
Phase phase 1
Sponsor Entegrion, Inc.
Start date November 2013
End date September 2016
Trial size 26 participants
Trial identifier NCT01589666, RSX-102

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
spray-dried s/d-treated plasma Resusix
Infusion of 100 mL Spray-dried S/D-treated Plasma
spray-dried s/d-treated plasma Resusix
Infusion of 200mL Spray-dried S/D-treated plasma
spray-dried s/d-treated plasma Resusix
Infusion of 500 mL Spray-dried S/D-treated plasma
spray-dried s/d-treated plasma Resusix
Infusion of 750 mL Spray-dried S/D-treated Plasma
spray-dried s/d-treated plasma Resusix
Infusion of 800 mL Spray-dried S/D-treated Plasma

Primary Outcomes

Measure
Incidence of treatment-emergent SAEs
time frame: 12 weeks

Secondary Outcomes

Measure
Change from baseline of select coagulation factors
time frame: 30 minutes post infusion
Incidence of AEs
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
Principal investigator Bradley Vince, DO
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Entegrion, Inc..