EryDex Pharmacokinetics in Healthy Volunteers

NCT01925859 | Completed Phase 1

• 1 other identifier: IED-PK01-2013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pharmacokinetic analysis; EryDex

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  84 days after infusion

Study Arms (1)

EryDex System

EXPERIMENTAL

erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)

Drug: EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)

Interventions

EryDex (dexamethasone sodium phosphate encapsulated erythrocytes) DRUG

erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug

Also known as: EryDex System (dexamethasone sodium phosphate encapsulated erythrocytes)

EryDex System

Eligibility Criteria

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

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

Sponsors & Collaborators

• Quince Therapeutics S.p.A.: lead

Study Sites (1)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Mohamed Al-Ibrahim, MD

  SNBL Pharmacology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 20, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 1, 2015

Record last verified: 2014-12

Locations

US (1)