Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components
This Phase I trial in healthy, post-menopausal women is designed as a double-blind, placebo-controlled, randomized, ascending single-dose safety trial. MF101 will be administered as a single oral dose to a total of 32 enrolled subjects between the ages of 40-65 years. Eight subjects will be assigned to each of four cohorts. Within each cohort, six subjects will be randomized to receive MF101 and two subjects will receive placebo. MF101 doses will be incrementally escalated until the stopping criteria are reached. If stopping criteria are reached before the fourth cohort receives dosing, the next cohort may receive a dose between the dose that was administered to the cohort exhibiting symptoms of MF101 toxicity and the next lower dose group.
Bionovo has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Oral, Dose Escalation Phase 1 Study to Evaluate the Safety and Tolerance of MF 101 as Well as the Pharmacokinetics of Its Key Active Components in Healthy Post-Menopausal Women.|
- Identify the highest oral dose of MF101 that is safe and tolerated in humans.
- Number and type of adverse events
- Clinical laboratory including: Chemistry, hematology, blood coagulation and urinalysis
- Physical exam and vital signs
- Characterize MF101 toxicity and associated clinical symptoms in healthy subjects.
- Establish cardiac safety (QTcB).
- Study the dose dependent pharmacokinetics of MF101's key active components after oral administration.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2007|
The primary goal of this study is to identify the highest safe oral dose of MF101 that is well tolerated in humans.
Secondary goals include: characterizing clinical symptoms of MF101 toxicity in healthy subjects and evaluating the dose-dependent pharmacokinetics of key MF101 active components after a single oral dose.
|United States, Colorado|
|University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80012|
|Principal Investigator:||Thomas Henthorn||University of Colorado, Denver|