HealthyPhase 1NCT02380924
Recovery and Survival of EryDex in Non-patient Volunteers
A Phase 1 study testing DSP loaded RBC using EryDex System in people with Healthy, run by Quince Therapeutics S.p.A. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DSP loaded RBC using EryDex System
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Have any other significant disease or condition that in the Investigator's opinion would put the subject at risk for participating in the trial, including acute gastric ulcer or diabetes.
- Vital signs persistently outside the following ranges:
- Systolic blood pressure <90 or >140 mmHg
- Diastolic blood pressure <50 or >90 mmHg
- Pulse <50 or >90 bpm. Patients with pulse rates <50 that are otherwise healthy will be eligible for the trial if approved by the Sponsor.
- Any clinically significant ECG abnormality
- Any clinically significant abnormality on standard laboratory examinations, as determined by the Investigator
- Positive serum pregnancy test
- Positive confirmed findings of an infectious disease based on results from the standard blood donor infectious disease screening panel
- Positive results of the drug or alcohol tests at baseline (Day 0 pre-dose) at the unit
- Any previous oral or parenteral steroid use <4 weeks before baseline. Treatment with inhaled or intranasal steroids for asthma or allergies, as well as use of topical steroids will be permitted
- Chronic condition or prior allergic reaction representing a contraindication to the use of dexamethasone or other steroid drugs
- Have participated in any other trial with an investigational drug and received a dose <30 days or 10 half-lives (whichever is greater) from the start of the screening period.
- Requirement for any concomitant medication prohibited by the protocol. Subjects with a history of treatment with oral or depot antipsychotic medication will be excluded
- A drug or treatment known to cause major organ system toxicity during the past year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03576
About this study
Official title: Determination of the in Vivo Recovery and Survival of EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) in Non-patient Volunteers
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).
Read the detailed description
EryDex System (EDS) is a combination product used to administer dexamethasone sodium phosphate (DSP) by ex vivo encapsulation in autologous erythrocytes which are re-infused. DSP is dephosphorylated in RBCs to release dexamethasone.
The 12 subjects who meet all of the inclusion/exclusion criteria will be assigned to one of the 2 groups, consisting of 6 subjects each, as follows:
- Group 1 (active drug arm): 15-20 mg DSP loaded in RBC using the EDS.
- Group 2 (sham arm): sham treated autologous RBC using the EDS
One 50±5mL aliquot of blood collected from each subject will be treated using the EDS process (either active drug or sham) and the resultant processed RBCs will be radiolabeled with Chromium-51 (51Cr) for the in vivo kinetic study. A second 10±5mL simultaneously collected sample will be labeled with Technetium-99m (99mTc) to estimate the subject's blood volume. These labeled aliquots will be mixed, and simultaneously infused through a peripheral vein via butterfly or similar catheter (total dose 20-40 μCi). Blood samples will be collected from the subject's contralateral arm immediately pre-infusion and at 5, 7.5, 10, 12.5, 15, 20, and 30 minutes (± 3 min), and on Day 1, 24 hours (±2 h) after completion of infusion. Vital signs will be assessed after the 30-min sample on Day 0 and again on Day 1 before the 24-h sample is collected. Additional blood samples will be collected at 48 (±4 h) and 72 (±4 h) hours and 7 (±1 d) days post-infusion, and then weekly through 49 days post-infusion, with a window of ±2 days for each visit.
- Conditions
- Healthy
- Being tested
- DSP loaded RBC using EryDex System, Sham treated RBC using the EryDex System
- Keywords
- subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP loaded RBC using EryDex SystemDrug
Also called EryDex System
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.
Sham treated RBC using the EryDex SystemDrug
Also called EryDex System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sham treated RBC using the EryDex System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 49 days
Secondary outcomes (1)
Special laboratory tests
pH at 37°C, hemolysis, ATP, 2,3-DPG, extracellular potassium, extracellular glucose, extracellular lactate, packed cell volume, RBC morphology and RBC indices. In particular free haemoglobin and and hematuria will be assessed on all defined time points.The measure is a composite outcome
Measured: up to 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quince Therapeutics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry J Dumont, PhD, MBA, Principal investigator, Dartmouth Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380924
- Sponsor's protocol ID
- Ery51Cr-01-2014
- Status last verified
- Jan 2016
- First submitted
- 16 Feb 2015
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the in Vivo Recovery and Survival of EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) in Non-patient Volunteers
- ClinicalTrials.gov ID
- NCT02380924
- Acronym / sponsor ID
- Ery51Cr-01-2014
- Conditions
- Healthy
- Keywords
- subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Quince Therapeutics S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
EryDex System (EDS) is a combination product used to administer dexamethasone sodium phosphate (DSP) by ex vivo encapsulation in autologous erythrocytes which are re-infused. DSP is dephosphorylated in RBCs to release dexamethasone.
The 12 subjects who meet all of the inclusion/exclusion criteria will be assigned to one of the 2 groups, consisting of 6 subjects each, as follows:
- Group 1 (active drug arm): 15-20 mg DSP loaded in RBC using the EDS.
- Group 2 (sham arm): sham treated autologous RBC using the EDS
One 50±5mL aliquot of blood collected from each subject will be treated using the EDS process (either active drug or sham) and the resultant processed RBCs will be radiolabeled with Chromium-51 (51Cr) for the in vivo kinetic study. A second 10±5mL simultaneously collected sample will be labeled with Technetium-99m (99mTc) to estimate the subject's blood volume. These labeled aliquots will be mixed, and simultaneously infused through a peripheral vein via butterfly or similar catheter (total dose 20-40 μCi). Blood samples will be collected from the subject's contralateral arm immediately pre-infusion and at 5, 7.5, 10, 12.5, 15, 20, and 30 minutes (± 3 min), and on Day 1, 24 hours (±2 h) after completion of infusion. Vital signs will be assessed after the 30-min sample on Day 0 and again on Day 1 before the 24-h sample is collected. Additional blood samples will be collected at 48 (±4 h) and 72 (±4 h) hours and 7 (±1 d) days post-infusion, and then weekly through 49 days post-infusion, with a window of ±2 days for each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSP loaded RBC using EryDex System | Active comparator | Drug: DSP loaded RBC using EryDex SystemAutologous RBC loaded with DSP using the EDS process, and treated RBC are infused to the subject. |
| Sham treated RBC using the EryDex System | Sham comparator | Drug: Sham treated RBC using the EryDex SystemAutologous RBC are treated with buffer using the EDS process, and treated RBC are infused to the subject. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSP loaded RBC using EryDex SystemAlso: EryDex SystemIntravenous 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. | Drug | DSP loaded RBC using EryDex System |
| Sham treated RBC using the EryDex SystemAlso: EryDex SystemIntravenous 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. | Drug | Sham treated RBC using the EryDex System |
Primary outcome
24-hour post transfusion recovery of infused autologous RBCs
Time frame: 24 hours
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.
Long-term survival of infused autologous RBCs assessed with T50 (Time to disappearance of 50% of the labelled red blood cells from the circulation)
Time frame: up to 49 days
For RBC T50 will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
1 secondary outcome
Special laboratory tests
Time frame: up to 49 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry J Dumont, PhD, MBA principal investigator
Dartmouth Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DSP loaded RBC using EryDex System in people with Healthy, run by Quince Therapeutics S.p.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour post transfusion recovery of infused autologous RBCs (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.