Results from the study are expected to validate dose response pharmacokinetics of TSX-011 along with safety and tolerability.
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[30-November-2017] |
SAN FRANCISCO, Nov. 30, 2017 /PRNewswire/ -- TesoRx Pharma LLC, a biopharmaceutical company, today announced it commenced enrollment for a Phase 1/2a clinical trial of TSX-011 in patients with hypogonadism. TSX-011 is a novel oral testosterone replacement therapy ("TRT") to treat adult males suffering from conditions associated with low endogenous testosterone, also known as hypogonadism. Results from the study are expected to validate dose response pharmacokinetics of TSX-011 (testosterone undecanoate) along with safety and tolerability. The open-label, three period study in hypogonadal males is expected to enroll 24 subjects. Efficacy will be assessed by measuring PK profiles in patients following a single ascending dose period, fixed twice-daily dose period and a dose-adjusted adaptive design period. Enrollment will include at least 10 evaluable native Japanese subjects intended to contribute towards TSX-011 regulatory approval efforts in Japan. "The commencement of this study signals an important milestone in the development of TSX-011," said Dr. TR Thirucote, Chairman and CEO of TesoRx. Dr. Michael Oefelein, Chief Medical Officer of the Company, added, "We look forward to announcing top-line results by the 2nd half of 2018 and advancing development towards approval in multiple major markets including the United States through our partnerships with Aspen Pharmacare and ASKA Pharmaceutical." About TSX-011 About TesoRx Pharma LLC About ASKA Pharmaceutical Co., Ltd.
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