广东恒瑞SHR - 1819注射液启动Ⅰ期临床 适应症为特应性皮炎

Core Viewpoint - Guangdong Heng Rui Medicine Co., Ltd. has initiated a clinical trial to evaluate the bioavailability and safety of SHR-1819 injection using different injection devices, with the trial registered under CTR20254700 and first disclosed on November 27, 2025 [1] Group 1: Clinical Trial Details - The clinical trial is a randomized, parallel, open study involving healthy subjects [1] - The trial aims to compare the bioavailability of SHR-1819 injection using pre-filled safety injection needles (PFS) and pre-filled automatic injection pens (AI) [1] - The primary endpoint includes comparing pharmacokinetic parameters Cmax and AUClast of SHR-1819 injection with different devices [1] Group 2: Drug Information - SHR-1819 injection is a biological product indicated for atopic dermatitis, a chronic, recurrent inflammatory skin disease characterized by itching, erythema, and papules [1] - Secondary endpoints include assessing the safety of SHR-1819 (vital signs, physical examination) and the positive occurrence rate and timing of anti-drug antibodies (ADA) [1] Group 3: Trial Status - The current status of the trial is ongoing (not yet recruiting) with a target enrollment of 160 participants [2]