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

Primary Purpose

Acute Radiation Syndrome

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RadProtect®
Sponsored by
Original BioMedicals Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Radiation Syndrome focused on measuring Acute Radiation Syndrome, ARS, Amifostine, Radio-protectants

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • SNBL Clinical Pharmacology CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RadProtect®

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
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

Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.
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).

Full Information

First Posted
October 26, 2015
Last Updated
October 26, 2015
Sponsor
Original BioMedicals Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02587442
Brief Title
A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
Official Title
A Phase I Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Original BioMedicals Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Radiation Syndrome
Keywords
Acute Radiation Syndrome, ARS, Amifostine, Radio-protectants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RadProtect®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RadProtect®
Intervention Description
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 Measure Information:
Title
Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
Description
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.
Time Frame
Day 0~ Day 28
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.
Description
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).
Time Frame
Day 0 ~ Day 1 (24 hours after dosing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Kan
Phone
+886-2-2697-1713
Ext
223
Email
sandykan@i-obm.com
First Name & Middle Initial & Last Name or Official Title & Degree
San Tseng
Phone
+886-2-2697-1713
Ext
222
Email
santseng@i-obm.com
Facility Information:
Facility Name
SNBL Clinical Pharmacology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galina Tucker
Phone
410-706-8772
Email
gtucker@snbl-cpc.com
First Name & Middle Initial & Last Name & Degree
Mohamed Al-Ibrahim

12. IPD Sharing Statement

Citations:
PubMed Identifier
26222219
Citation
Chen CH, Kuo ML, Wang JL, Liao WC, Chang LC, Chan LP, Lin J. CCM-AMI, a Polyethylene Glycol Micelle with Amifostine, as an Acute Radiation Syndrome Protectant in C57BL/6 Mice. Health Phys. 2015 Sep;109(3):242-8. doi: 10.1097/HP.0000000000000326.
Results Reference
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A Study to Evaluate the Safety and Pharmacokinetics of RadProtect® in Healthy Volunteers

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