Recovery and Survival of EryDex in Non-patient Volunteers

NCT02380924 | Completed Phase 1

• 1 other identifier: Ery51Cr-01-2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-blind, single-center, concurrently controlled, exploratory, Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50 survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).

Conditions

Healthy

Keywords

subjects

Outcome Measures

Primary Outcomes (2)

• 24-hour post transfusion recovery of infused autologous RBCs

  The 24-hour recovery of autologous RBCs loaded with DSP or sham using the EDS will be greater than 75% with 95% confidence. For RBC kinetics and recovery will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.

  24 hours

• Long-term survival of infused autologous RBCs assessed with T50 (Time to disappearance of 50% of the labelled red blood cells from the circulation)

  For RBC T50 will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.

  up to 49 days

Secondary Outcomes (1)

• Special laboratory tests

  up to 49 days

Other Outcomes (5)

• Safety: Physical exam

  up to 49 days

• Safety: Number of abnormal ECGs

  up to 49 days

• Safety: Number of adverse events

  up to 49 days

Study Arms (2)

DSP loaded RBC using EryDex System

ACTIVE COMPARATOR

Autologous RBC loaded with DSP using the EDS process, and treated RBC are infused to the subject.

Drug: DSP loaded RBC using EryDex System

Sham treated RBC using the EryDex System

SHAM COMPARATOR

Autologous RBC are treated with buffer using the EDS process, and treated RBC are infused to the subject.

Drug: Sham treated RBC using the EryDex System

Interventions

DSP loaded RBC using EryDex System DRUG

Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.

Also known as: EryDex System

DSP loaded RBC using EryDex System

Sham treated RBC using the EryDex System DRUG

Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.

Also known as: EryDex System

Sham treated RBC using the EryDex System

Eligibility Criteria

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

You may qualify if:

• If female of childbearing potential\*, the subject agrees not to donate ova and to use one of 4 methods of contraception from the time of signing the informed consent until 2 months after infusion
• If male, the subject agrees to not donate sperm and to use barrier contraception (e.g., condom with spermicidal cream or jelly) from the time of signing the informed consent until 2 months after infusion
• Physically and mentally healthy, as confirmed by medical history, physical examination, vital signs, clinical laboratory tests, and ECG
• Meets current physical examination guidelines for whole blood donation as set forth by the AABB (Reference Standard 5.4.1A, Standards for Blood Banks and Transfusion Services, 28th edition. Bethesda. TH Carson ed. 2012). Past travel restrictions do not apply for selection of subjects for this study
• Hemoglobin: ≥ 12.5g/dL
• Temperature: ≤ 37.5°C
• Ability to understand the objectives of the trial and comply with the study procedures

You may not qualify if:

• Females that are of childbearing potential, pregnant, or are breast-feeding Women of childbearing potential using two forms of birth control (e.g. barrier and hormonal) will be eligible
• Loss/removal of 500 mL or more of blood \<4 weeks
• A disability that may prevent the subject from completing all study requirements
• Noncompliance with the study requirements
• Current participation in another clinical study
• Significant occupational exposure to ionizing radiation
• Current or previous neoplastic disease
• History of any impairment of the immunological system
• History of drug or alcohol abuse (\<5 years)
• A current diagnosis of severe or unstable cardiovascular disease.
• Any history or current evidence of a cardiac illness as determined by the investigator.
• History or current diagnosis of a psychiatric illness, other than an anxiety disorder, or neurodegenerative disorder.
• History of hemoglobinopathy or G6PD deficiency.
• History of recurrent or chronic infections
• History of tuberculosis

Sponsors & Collaborators

• Quince Therapeutics S.p.A.: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03576, United States

Location

Study Officials

• Larry J Dumont, PhD, MBA

  Dartmouth Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

US (1)