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

NCT01589666 | Completed Phase 1 DMC

• 1 other identifier: RSX-102
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation Defects

Keywords

Entegrion; Spray-dried Solvent/Detergent Plasma; Fresh Frozen Plasma; Transfusion; Resuscitation; Hemorrhage; Coagulopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent SAEs

  Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion

  12 weeks

Secondary Outcomes (2)

• Change from baseline of select coagulation factors

  30 minutes post infusion

• Incidence of AEs

  12 weeks

Study Arms (1)

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.

Biological: Spray-dried S/D-treated Plasma; Drug: Spray-dried S/D-treated plasma

Interventions

Spray-dried S/D-treated Plasma BIOLOGICAL

Infusion of 100 mL Spray-dried S/D-treated Plasma

Also known as: Resusix

Spray-dried S/D-treated plasma

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Body temperature within 97°F to 99°F
• Heart rate 45 to 100 beats per minute (bpm)
• Systolic blood pressure (SBP) within 90 to 140 mmHg and DBP within 50 to 90 mmHg.
• Subject must have a normal (no clinically significant abnormality) EKG at Screening and prior to administration of Resusix
• PR interval within 120 and 200 mm/s
• QRS interval \<120 mm/s
• QTc interval ≤440 mm/s
• Subject must have laboratory hematology values within following normal ranges:
• White blood cell count (WBC): 4,500 to 11,000/mL
• Platelet (PLT) count: 150,000 to 400,000/mL;

You may not qualify if:

• Subject with lower extremity deep vein thrombosis (DVT) at Screening.
• Subject has a history of coagulopathy or thromboembolic disease.
• 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.
• Subject has documented drug allergies with well-described reactions.
• Subject has hepatomegaly, splenomegaly, adenopathy, bruising, and/or ecchymoses identified at Screening.
• Subject is found to have positive NAT test for HIV, HBV or HCV.
• Subject has any murmurs, rubs, or gallops on cardiac auscultation.
• Subject has had a previous transfusion at any time.
• 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.

Sponsors & Collaborators

• Entegrion, Inc.: lead

Study Sites (1)

Vince & Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bradley Vince, DO

  Vince & Associates Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: May 2, 2012
• Study Start: November 1, 2013
• Primary Completion: September 9, 2016
• Study Completion: September 9, 2016
• Last Updated: February 7, 2017

Record last verified: 2017-02

Locations

US (1)