[Translation] A randomized, multicenter, dose-escalation, treatment extension phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of TISA-818 oral rinse administered topically via the oral mucosa for the prevention and treatment of radiation oral mucositis in patients with head and neck cancer
主要目的是评估TISA-818含漱液在头颈部肿瘤患者中的安全性、有效性和耐受性;次要目的是考察TISA-818含漱液在头颈部肿瘤患者中的药代动力学(PK)特征。
[Translation] The primary objective is to evaluate the safety, efficacy, and tolerability of TISA-818 oral rinse in patients with head and neck cancer; the secondary objective is to investigate the pharmacokinetic (PK) characteristics of TISA-818 oral rinse in patients with head and neck cancer.