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绿叶制药(02186)抗抑郁1类创新药完成1期临床首例受试者入组
智通财经网· 2025-08-04 03:40
Core Insights - Green Leaf Pharmaceutical (02186) has announced the completion of the first subject enrollment in a Phase I clinical study for its innovative drug LY03021 in China, which is designed to treat depression [1][2] Group 1: Drug Mechanism and Development - LY03021 is a novel antidepressant that acts as a norepinephrine transporter (NET) and dopamine transporter (DAT) inhibitor, as well as a positive allosteric modulator of the GABA A receptor (GABAAR) [1] - The drug targets three mechanisms: NET, DAT, and GABAAR, aiming to enhance the balance of glutamate and GABA in the brain, thereby quickly exerting antidepressant effects [1][2] Group 2: Clinical Study Details - The Phase I clinical trial is a single-center, randomized, double-blind, placebo-controlled, dose-escalation study aimed at assessing the safety, tolerability, and pharmacokinetic characteristics of LY03021 in healthy subjects [2] - Non-clinical studies indicate that LY03021 significantly improves depressive symptoms in model animals within 24 hours of administration, with stable efficacy observed over a 21-day treatment period [2] Group 3: Safety Profile - LY03021 demonstrates a favorable safety profile, with a no-observed-adverse-effect level (NOAEL) exceeding 50 times the effective dose [2]