NCT00453297

Phase I Study to Evaluate the Safety and Efficacy of MF101 as Well as the Pharmacokinetics of Its Key Active Components

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.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Bionovo · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MF101

Timeline

• Start date: 2006-10-01
• Completion: 2007-04-01
• First posted: 2007-03-28
• Last updated: 2008-08-29

Locations

1 site across 1 country: United States