EryDex Pharmacokinetics in Healthy Volunteers
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: EryDex System erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System) |
Drug: EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)
erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug
Other Names:
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Outcome Measures
Primary Outcome Measures
- Pharmacokinetic comparison of two different doses of EryDex in two independent groups [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.
Secondary Outcome Measures
- Evaluation of safety and tolerability of a single infusion of EryDex administered in two different doses in healthy volunteers [84 days after infusion]
• 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages 18-55 years, inclusive.
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If female, the subject is not pregnant or lactating, and has negative serum pregnancy tests at Screening and Baseline (check-in).
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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.
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Cap or diaphragm with spermicidal cream or jelly + male condom and spermicide.
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Hormonal contraceptives (oral, implant, injection or patch) + male condom and spermicide.
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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).
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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.
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Physically and mentally healthy, as confirmed by medical history, physical examination, vital signs, clinical laboratory tests, and ECG.
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The subject has a body weight of at least 45 kg and a body mass index of ≤ 30.
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Written informed consent to participate was obtained from the subject.
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Ability to understand the aims of the trial and comply with the study procedures.
Exclusion Criteria:
- General
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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.
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Loss/removal of 500 mL or more of blood within the past 4 weeks.
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A disability that may prevent the subject from completing all study requirements.
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Noncompliance with the study requirements. Medical History
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Current or previous neoplastic disease.
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History of any impairment of the immunological system.
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History of drug or alcohol abuse (within past 5 years).
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A current diagnosis of severe or unstable cardiovascular disease;
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Any history or current evidence of a cardiac illness as determined by the investigator;
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History or current diagnosis of a psychiatric illness (DSM-IV-TR Axis I diagnosis) or neurodegenerative disorder.
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Smoker; currently or at any time in the last 6 months.
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Hemoglobinopathy or G6PD deficiency.
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History of recurrent or chronic infections, including Staphylococcus or methicillin-resistant Staphylococcus aureus (MRSA).
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History of positive tuberculosis skin test (PPD test). Current Medical Status
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Have any other significant disease or condition that in the Investigator's opinion would put the subject at risk for participating in the trial.
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Vital signs outside the following ranges:
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Systolic blood pressure <90 or >140 mmHg
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Diastolic blood pressure <50 or >90 mmHg
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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.
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Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes.
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Any clinically significant abnormality on standard laboratory examinations (hematology, biochemistry, urinalysis), as determined by the Investigator, in consultation with the Sponsor.
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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).
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Positive results from the HIV serology.
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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
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Clinically significant abnormal serum cortisol levels (below normal range or
1.5x ULN) at screening.
Prior/Concomitant Medication
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Any previous steroid consumption within 4 weeks before Baseline.
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Chronic condition or prior allergic reaction representing a contraindication to the use of steroid drugs.
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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.
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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.
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A drug or treatment known to cause major organ system toxicity during the past year.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | SNBL Clinical Pharmacology Center | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Erydel
Investigators
- Principal Investigator: Mohamed Al-Ibrahim, MD, SNBL Pharmacology Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IED-PK01-2013