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American BriVision Conducts Site Monitoring Visit for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD)
PDC-1421, the active ingredient of ABV-1505, is being expanded into Adult ADHD trials following encouraging Phase II trial results in major depressive
About this update from Abvc Biopharma, Inc.
[{"type":"text","content":" PDC-1421, the active ingredient of ABV-1505, is being expanded into Adult ADHD trials following encouraging Phase II trial results in major depressive disorder (MDD) A site monitoring visit for the on-going Phase II Part I trial of ABV-1505 for the treatment of Adult ADHD was conducted at the University of California, San Francisco (UCSF) Medical Center on March 10 and 11, 2020 Phase II Part II trial of ABV-1505 is expected to follow Part I and be conducted at UCSF and major medical centers in Taiwan FREMONT, CA, April 06, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – American BriVision (Holding) Corporation (OTCQB: ABVC) (the “Company”), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS and ophthalmology, today announced that a site monitoring visit was conducted on March 10 and March 11, 2020 at the University of California San Francisco (UCSF) Medical Center for ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001, for Adult Attention-Deficit Hyperactivity Disorder (ADHD). \n This trial is an open label, single-center and dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive a low-dose treatment (380 mg) of PDC-1421 Capsules three times daily for 28 days followed by a high-dose treatment (760 mg) three times daily for another 28 days. As of the site monitoring visit, four qualified adult ADHD patients had been enrolled and treated with PDC-1421 Capsules. Among them, two will complete their treatment of PDC-1421 according to the study protocol on April 8 and April 11, 2020 respectively. The overall site monitoring visit went well with several minor errors cited and corrected subsequently. The primary objective of this study is to determine the effective doses and treatment period of PDC-1421 Capsules in adult patients with ADHD. The secondary objective is to evaluate the conditions of the patients receiving the drug at various dose levels. A Phase II Part II study is expected to follow at the UCSF Medical Center, along with major medical centers in Taiwan, assuming successful completion of this Phase II Part I study. “We are pleased to announce that our Phase II Part I trial of ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD) is proceed...