Clinical trial NCT01589666: Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
Official title: Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coagulation Defects
Keywords: Entegrion
Spray-dried Solvent/Detergent Plasma
Fresh Frozen Plasma
Transfusion
Resuscitation
Hemorrhage
Coagulopathy
Lead sponsor: Entegrion, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment-emergent SAEs
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline of select coagulation factors
timeFrame: 30 minutes post infusion
measure: Incidence of AEs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research
state: Kansas
Study officials:
affiliation: Vince & Associates Clinical Research, Inc.
name: Bradley Vince, DO
role: PRINCIPAL_INVESTIGATOR
References: