[Translation] Phase I/II clinical trial of the safety, tolerability and preliminary efficacy of DK001 in the treatment of complex anal fistulas in Crohn's disease
主要目的:明确DK001治疗克罗恩病的复杂性肛瘘的安全性和耐受性,为后续试验确定临床用药的安全范围和推荐剂量;
次要目的:初步观察DK001治疗克罗恩病的复杂性肛瘘的有效性,为后续确证性临床试验设计提供依据。
[Translation] Primary purpose: To clarify the safety and tolerability of DK001 in the treatment of complex anal fistulas in Crohn's disease, and to determine the safety range and recommended dose of clinical medication for subsequent trials;
Secondary purpose: To preliminarily observe the effectiveness of DK001 in the treatment of complex anal fistulas in Crohn's disease, and to provide a basis for the design of subsequent confirmatory clinical trials.