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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Acute Radiation Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RadProtect®

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes