Clinical trial NCT02587442: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Radiation Syndrome
Keywords: Acute Radiation Syndrome
ARS
Amifostine
Radio-protectants
Lead sponsor: Original BioMedicals Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
measure: Safety and tolerability profile including the dose limiting toxicity (DLT) of RadProtect® intravenous injection to healthy volunteers.
timeFrame: Day 0~ Day 28
Secondary outcomes:
measure: Pharmacokinetic (PK) parameters of RadProtect® by analyzing subjects' serum for free WR-1065 at different time points.
timeFrame: Day 0 ~ Day 1 (24 hours after dosing)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
References:
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.