Safety and Pharmacokinetic Study of BIO 300 Capsules
Acute Radiation Syndrome
About this trial
This is an interventional treatment trial for Acute Radiation Syndrome focused on measuring Acute Radiation Syndrome, Hematopoietic Syndrome, Radiation Injury, BIO 300
Eligibility Criteria
Inclusion Criteria:
Healthy male and female subjects, age 18-64, who have signed the consent form
- Subjects with a body mass index (BMI) 18-30 kg/m2
- Subjects who are willing to abstain from sex or use a barrier method of birth control (Women 1 week, Men 4 months after leaving the trial)
- Subjects with a negative pregnancy test and drug screen
- Subjects with laboratory values within normal limits (CBC/differential, CMP, enzymes, ECG, vital signs, urinalysis)
- Subjects with ability to comprehend and complete the questionnaires and forms
- Subjects who are likely to comply with study procedures and test article consumption
- Subjects whose schedules permit a 10-12 hour stay in the clinic followed by daily evaluations for one week (7 days)
- Subjects who are available for a 14-day follow up phone call (women) and 4-month follow up phone call (men).
- Subjects who are likely to abstain from taking unauthorized medications or supplements or participating in any other clinical trial or experimental treatment during this trial
- Subjects who are likely to follow the low isoflavone diet program
Exclusion Criteria:
· Subjects with any allergic reaction or sensitivity to soy, isoflavones, or any component of the test article product
- Subjects who consume >5 alcoholic beverages per week
- Subjects who are pregnant, lactating, or at risk of becoming pregnant
- Subjects who have blood (or urine) levels outside the normal range for any of the hepatic, renal, hematologic, lipid or coagulation parameters measured.
- Subjects on Hormone Replacement Therapy or Birth Control Pills within the past three months.
- Subjects on any other clinical trial or experimental treatment in the past 3 months
- Subjects with a history of diabetes (Type 1 or Type 2 diabetes mellitus) or other endocrine disorders, uncontrolled hypertension, prior cerebrovascular accident or seizure disorder, cardiovascular, hepatic or renal disease, active cancer, hematologic disorder, thromboembolic disease, or HIV infection.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
500 BIO 300 capsule
1000 BIO 300 capsule
1500 BIO 300 capsule
2000 BIO 300 capsule
The first cohort will receive one 500 BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting
the second cohort will be treated with 1000 mg BIO 300 using the same PK sampling program
the third cohort will be treated with 1500 mg BIO 300using the same PK sampling program
the forth cohort will be treated with 2000 mg BIO 300using the same PK sampling program