Clinical Studies on Oral Drug
RANDOMIZED, DOUBLE-BLIND, SINGLE RISING-DOSE STUDY OF S-EQUOL IN NORMAL VOLUNTEERS
An initial single rising-dose Phase 1 clinical trial was conducted in healthy male and female volunteers to evaluate the safety and pharmacokinetics of AUS-131. AUS-131 was well tolerated at all doses tested and exhibited favorable pharmacokinetics suitable for twice-daily dosing. Study results have been published in the February 2011 issue of Menopause.
RANDOMIZED, DOUBLE-BLIND, RISING MULTIPLE DOSE STUDY OF S-EQUOL IN NORMAL VOLUNTEERS
A second, multiple-dose, placebo-controlled Phase 1 clinical trial was initiated in December 2008. In this study, healthy males and females were given AUS-131 twice daily at doses ranging from 10 mg (total daily dose of 20 mg) to 160 mg (total daily dose of 320 mg) for 2 weeks. Results demonstrated the safety of AUS-131 and an excellent pharmacokinetic profile at all doses tested. Results of both Phase 1 studies were recently published in the February 2011 issue of Menopause.
ONGOING STUDIES
Ausio has initiated two Phase 2a “proof-of-concept” studies: one examining the effects of AUS-131 on vasomotor symptoms (VMS) (hot flashes and night sweats) in menopausal women and the other examining the effects of AUS-131 in men with benign prostatic hyperplasia (BPH). Both studies are multicenter, double-blind, randomized, placebo-controlled dose-response studies, with clinical sites in the United States and Australia. Results are expected in Q3 of 2011.