Safety and Pharmacokinetic Study of BIO 300 Capsules
This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for use starting at 500 mg.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Escalation Trial Evaluating the Safety and Pharmacokinetic Profiles of BIO 300 Capsules in Healthy Male and Female Volunteers|
- Safety as assessed by lab work and adverse event monitoring [ Time Frame: 1 month for females & 4 months for males ]
- Pharmacokinetic assessment by analyzing patient serum for free and total BIO 300 content at multiple time points. [ Time Frame: 7 days ]
|Study Start Date:||June 2007|
|Study Completion Date:||October 2007|
500, 1000, 1500, 2000
This study will have 4 arms or cohorts. Each cohort will be tested at an escalating dose of BIO 300; 500 mg, 1000 mg, 1500 mg & 2000 mg.
|Drug: BIO 300 Capsules|
This clinical trial will assess the safety and PK of BIO 300 capsules at doses expected to deliver a radioprotective or therapeutic effect in humans. Humanetics is planning to conduct this Phase I, single dose, dose-escalation (500, 1000, 1500, and 2000 milligrams) study of the safety, tolerability and pharmacokinetics of BIO 300 by recruiting approximately 24 healthy men and women between the ages of 18 and 64 to be enrolled in cohorts of 6 subjects per group. The first cohort will receive one 500 mg BIO 300 capsule and pharmacokinetic blood sampling will be conducted over the first 4 days in an outpatient setting at a clinic skilled in this type of Phase I trial. Blood samples will be analyzed for BIO 300 levels, hematology, chemistry, lipid profiles, phosphorus, clotting factors and fibrinogen as well as pancreatic lipase and amylase. Urinalysis will assess kidney function as well as creatinine clearance and BIO 300 clearance. All subjects will be monitored for adverse events and the safety of BIO 300 capsules will be evaluated in this setting. After review of all safety information and provided no clinically significant negative findings are revealed, the second cohort will be treated with 1000mg BIO 300 (two 500mg capsules) using the same PK sampling program. Again safety concerns will be reviewed and provided no clinically significant negative findings are revealed, the third and fourth cohort will be treated with 1500 and 2000 mg, respectively, of BIO 300 using the same PK sampling program.
|United States, Minnesota|
|MAPS Applied Research Center|
|Edina, Minnesota, United States, 55435|
|Principal Investigator:||John L Zenk, MD||Humanetics Corporation|