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



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 64
Updated:4/21/2016
Start Date:October 2015
Contact:Sandy Kan
Email:sandykan@i-obm.com
Phone:+886-2-2697-1713

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

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).


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.
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Mohamed Al-Ibrahim
Phone: 410-706-8772
?
mi
from
Baltimore, MD
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