American BriVision First Patient Enrolled for Adult ADHD Trial

American BriVision announced the first patient enrollment of 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). The new study will be conducted at the University of California San Francisco (UCSF) Medical Center.

This trial is an open label, single-center, dose escalation study designed for the enrollment of six adult ADHD patients. Each patient will receive a low-dose treatment (380 mg) thrice daily for 28 days followed by a high-dose treatment (760 mg) thrice daily for another 28 days. PDC-1421, the active pharmaceutical ingredient of ABV-1505, has been successfully evaluated in a recently completed Phase II study for major depressive disorder (MDD) conducted at Stanford University and five major medical centers in Taiwan, China.

The primary objective of this study is to determine the effective doses and treatment period of PDC-1421 in adult patients with ADHD. The secondary objective is to evaluate the safety of PDC-1421 in patents 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, China, after and assuming successful completion of this Phase II Part I study.

"We are excited to have the first patient enrolled at UCSF Medical Center to kick off the clinical evaluation of PDC-1421 therapeutic benefits in adult ADHD patients," said Dr. Howard Doong, Chief Executive Officer of the Company.

Register as Visitor to CPhI China 2020!

-----------------------------------------------------------------------
Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the articles,

please email: Julia.Zhang@imsinoexpo.com to motify or remove the content.