EryDex Pharmacokinetics in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01925859

Run by

Quince Therapeutics S.p.A.

People needed

18

Starts

2013-06-01

Expected to finish

2013-10-01

Last updated by the study team

2015-06-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• SNBL Clinical Pharmacology Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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