Trial | NCT02587442  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    amifostine ...

  • Study Participants

    27
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).
Study Started
Oct 31
2015
Primary Completion
Mar 31
2016
Anticipated
Last Update
Oct 27
2015
Estimate

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.

RadProtect® Experimental

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.

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.
No Results Posted