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A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02587442
Recruitment Status : Unknown
Verified October 2015 by Original BioMedicals Co. Ltd..
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Information provided by (Responsible Party):
Original BioMedicals Co. Ltd.

Brief Summary:
This is a Phase 1, non-randomized, sequential-cohort, dose escalation, open-label study designed to evaluate the safety and tolerability of RadProtect® in healthy volunteers. This study is to be conducted at two clinical centers and in conformity with Good Clinical Practice (GCP).

Condition or disease Intervention/treatment Phase
Acute Radiation Syndrome Drug: RadProtect® Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
Study Start Date : October 2015
Estimated Primary Completion Date : March 2016

Arm Intervention/treatment
Experimental: RadProtect®
RadProtect® is not a full-closed micelle, and uses ferrous iron to provide linkage between PEG-b-PGA and amifostine. Transferrin and other related proteins can chelate with ferrous iron and break the micelle releasing amifostine into the blood stream.
Drug: RadProtect®
This study will evaluate RadProtect® at sequential, escalating dose levels. Once administration is given, study subjects will be followed during 24 hours of hospitalization according to the final injection timing. All subjects will need to return to the hospital for monitoring at 7+2 days after dosing, and follow-up visits by telephone at Day 3, Day 14+2, and Day 28+2 days will need to be conducted.




Primary Outcome Measures :
  1. Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers. [ Time Frame: Day 0~ Day 28 ]
    DLT is defined as a subject's symptom worse than a Grade 2, with the exception of the value for Total Protein and Cholesterol that should be determined by the investigator as these values may be affected by diet and there may be no discomfort or immediate risk for subjects. During the telephone visits on Day 3, 14+2, and 28+2 after injection, the study coordinator will confirm the subject's status, report to the investigators, and will schedule extra hospital visits if necessary.


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points. [ Time Frame: Day 0 ~ Day 1 (24 hours after dosing) ]
    PK samples will be obtained from the arm opposite the side of infusion. A total of approximately 4 mL of whole blood per collection time point per subject will be collected for the PK analysis. There will be a total of 10 or 16 times during this study when the sampling times for PK analysis will take place (this will depend on the dosing group).



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Each subject must be willing and able to provide written informed consent for the study
  • Healthy volunteer subjects of both genders, aged 18-64 years old, and any race/ethnicity
  • Subjects with normal blood pressure (between ranges of 120-140/60-80 mmHg) at screening and baseline
  • Subjects with a body mass index (BMI) 18-30 kg/m2
  • Men or woman of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during screening, while receiving the investigational drug, and for 60 days after stopping the investigational drug
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening
  • Subjects with physiological examination and laboratory values within normal limits (CBC/differential, blood chemistry, iron, Total Iron Binding Capacity (TIBC), urinalysis, ECG and vital signs)
  • Subjects with the ability to comprehend and complete the telephone visits, screening, and site visits
  • Subjects must be able to adhere to dose and visit schedules
  • Subjects who agree to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial.

Exclusion Criteria:

  • Subjects with any allergic reaction or sensitivity to glutamate acid, polyethylene glycol, or any component of the test article product
  • Subjects who consume > five alcoholic beverages per week
  • Subjects who are pregnant or lactating
  • Subjects who have blood (or urine) levels outside the normal range for any hepatic, renal, hematologic, lipid or coagulation parameters measured.
  • Subjects on Hormone Replacement Therapy within the past three months
  • Subjects in any other clinical trial or experimental treatment in the past three months
  • Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, hypertension, hypotension or systolic blood pressure below 80 mmHg, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587442


Contacts
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Contact: Sandy Kan +886-2-2697-1713 ext 223 sandykan@i-obm.com
Contact: San Tseng +886-2-2697-1713 ext 222 santseng@i-obm.com

Locations
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United States, Maryland
SNBL Clinical Pharmacology Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Galina Tucker    410-706-8772    gtucker@snbl-cpc.com   
Principal Investigator: Mohamed Al-Ibrahim         
Sponsors and Collaborators
Original BioMedicals Co. Ltd.

Publications:
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Responsible Party: Original BioMedicals Co. Ltd.
ClinicalTrials.gov Identifier: NCT02587442     History of Changes
Other Study ID Numbers: OBM-A01-H001
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015
Keywords provided by Original BioMedicals Co. Ltd.:
Acute Radiation Syndrome
ARS
Amifostine
Radio-protectants
Additional relevant MeSH terms:
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Radiation Injuries
Acute Radiation Syndrome
Wounds and Injuries
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs