HealthyPhase 1EryDexNCT01925859
EryDex Pharmacokinetics in Healthy Volunteers
A Phase 1 study testing EryDex (dexamethasone sodium phosphate encapsulated erythrocytes) in people with Healthy, run by Quince Therapeutics S.p.A. at 1 site in United States.
Trial summary
To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy volunteers, based on plasma concentrations of dexamethasone. 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?
- EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Oct 2013
- 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
- Ages 18-55 years, inclusive.
- If female, the subject is not pregnant or lactating, and has negative serum pregnancy tests at Screening and Baseline (check-in).
- If female of childbearing potential*, the subject agrees not to donate ova and to use one of the following methods of contraception from the time of signing the informed consent until 2 months after infusion.
- Cap or diaphragm with spermicidal cream or jelly + male condom and spermicide.
- Hormonal contraceptives (oral, implant, injection or patch) + male condom and spermicide.
- Intrauterine devices + male condom or spermicide.
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- Vaginal ring + male condom and spermicide.
- Non-childbearing potential is defined as surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), hysterectomy at least 3 months before the start of the study, or postmenopausal (defined as continuous amenorrhea for at least 2 years).
- 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.
- The subject has a body weight of at least 45 kg and a body mass index of ≤ 30.
- Written informed consent to participate was obtained from the subject.
- Ability to understand the aims of the trial and comply with the study procedures.
Who cannot join
- General
- 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 within the past 4 weeks.
- A disability that may prevent the subject from completing all study requirements.
- Noncompliance with the study requirements. Medical History
- Current or previous neoplastic disease.
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- History of any impairment of the immunological system.
- History of drug or alcohol abuse (within past 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 (DSM-IV-TR Axis I diagnosis) or neurodegenerative disorder.
- Smoker; currently or at any time in the last 6 months.
- Hemoglobinopathy or G6PD deficiency.
- History of recurrent or chronic infections, including Staphylococcus or methicillin-resistant Staphylococcus aureus (MRSA).
- History of positive tuberculosis skin test (PPD test). Current Medical Status
- Have any other significant disease or condition that in the Investigator's opinion would put the subject at risk for participating in the trial.
- Vital signs 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, including a disorder of rate, rhythm, or conduction, or other morphological changes.
- Any clinically significant abnormality on standard laboratory examinations (hematology, biochemistry, urinalysis), as determined by the Investigator, in consultation with the Sponsor.
- History of hepatitis B and/or C, and/or positive serology results, which indicate the presence of hepatitis B and/or C (Hepatitis B surface antigen and/or antibody to Hepatitis C).
- Positive results from the HIV serology.
- Positive results of the drug and alcohol tests at screening and/or check-in at the unit. Alcohol intake should be limited to 2 drinks per day during the 2 weeks prior to dosing; alcohol consumption will be prohibited from the time o
- Clinically significant abnormal serum cortisol levels (below normal range or >1.5x ULN) at screening.
- Prior/Concomitant Medication
- Any previous steroid consumption within 4 weeks before Baseline.
- Chronic condition or prior allergic reaction representing a contraindication to the use of steroid drugs.
- Have participated in any other trial with an investigational drug and received a dose within 30 days or 10 half-lives (whichever is greater) from the start of the Screening Period.
- Requirement for any prescription or over-the-counter (OTC) medication, other than hormonal birth control or occasional use of acetaminophen, that cannot be discontinued during screening, at least one week before Baseline, and throughout the 42-day study period.
- f admittance on Day -1 through to the final safety evaluations on Day 42.
- A drug or treatment known to cause major organ system toxicity during the past year.
- Caffeine-containing products in excess of the equivalent of 2 cups of coffee per day during the 2 weeks prior to dosing and through to the final safety evaluations on Day 42.
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: Pharmacokinetics Study to Measure Plasma Concentrations of Dexamethasone Following EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) Infusion in Healthy Volunteers
To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy volunteers, based on plasma concentrations of dexamethasone.
- Conditions
- Healthy
- Being tested
- EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)
- Keywords
- Pharmacokinetic analysis, EryDex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)Drug
Also called EryDex System (dexamethasone sodium phosphate encapsulated erythrocytes)
erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug
| Study group | Role | What they receive |
|---|---|---|
| EryDex System | Experimental | erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System) Receives: Drug: EryDex (dexamethasone sodium phosphate encapsulated erythrocytes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic comparison of two different doses of EryDex in two independent groups
- To compare the pharmacokinetic (PK) properties of 2 different doses of EryDex (dexamethasone sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy volunteers, based on plasma concentrations of dexamethasone.
Measured: 42 days after infusion
Secondary outcomes (1)
Evaluation of safety and tolerability of a single infusion of EryDex administered in two different doses in healthy volunteers
- To evaluate the safety and tolerability of a single infusion of EryDex, administered at 2 different doses in healthy volunteers, based on the following: Treatment-Emergent Adverse Events (TEAEs), Serious AEs (SAEs), laboratory parameters, vital signs, ECGs and physical examination findings.
Measured: 84 days after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quince Therapeutics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed Al-Ibrahim, MD, Principal investigator, SNBL Pharmacology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925859
- Sponsor's protocol ID
- IED-PK01-2013
- Acronym
- EryDex
- Status last verified
- Dec 2014
- First submitted
- 14 Aug 2013
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study to Measure Plasma Concentrations of Dexamethasone Following EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) Infusion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01925859
- Acronym / sponsor ID
- EryDex / IED-PK01-2013
- Conditions
- Healthy
- Keywords
- Pharmacokinetic analysis, EryDex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Quince Therapeutics S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 20 Aug 2013 (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.
To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy volunteers, based on plasma concentrations of dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EryDex System | Experimental | Drug: EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Ages 18-55 years, inclusive.
- If female, the subject is not pregnant or lactating, and has negative serum pregnancy tests at Screening and Baseline (check-in).
- If female of childbearing potential*, the subject agrees not to donate ova and to use one of the following 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.
Key exclusion criteria (34 listed)
- General
- Prior/Concomitant Medication
- f admittance on Day -1 through to the final safety evaluations on Day 42.
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 |
|---|---|---|
| EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)Also: EryDex System (dexamethasone sodium phosphate encapsulated erythrocytes)erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug | Drug | EryDex System |
Primary outcome
Pharmacokinetic comparison of two different doses of EryDex in two independent groups
Time frame: 42 days after infusion
• To compare the pharmacokinetic (PK) properties of 2 different doses of EryDex (dexamethasone sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy volunteers, based on plasma concentrations of dexamethasone.
1 secondary outcome
Evaluation of safety and tolerability of a single infusion of EryDex administered in two different doses in healthy volunteers
Time frame: 84 days after infusion
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 Jun 2015.
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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.
Mohamed Al-Ibrahim, MD principal investigator
SNBL Pharmacology 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 EryDex (dexamethasone sodium phosphate encapsulated erythrocytes) 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 13 inclusion and 34 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 Jun 2015. 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. 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?
Pharmacokinetic comparison of two different doses of EryDex in two independent groups (time frame: 42 days after infusion). 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 Jun 2015.