[Translation] A randomized, double-blind, placebo-controlled Phase I clinical trial of BEBT-305 in healthy volunteers and patients with moderate-to-severe plaque psoriasis
在健康志愿者的临床试验:
主要目的:评估BEBT-305在健康志愿者中的安全性和耐受性;评估BEBT-305在健康志愿者体内的药代动力学特征;评估食物对BEBT-305药代动力学的影响。
在中重度斑块型银屑病患者的临床试验 :
主要目的:评估BEBT-305在中重度斑块型银屑病患者中的安全性和耐受性。 次要目的:评估BEBT-305在中重度斑块型银屑病患者体内的药代动力学特征;探索BEBT-305治疗中重度斑块型银屑病患者的有效剂量,即II期临床试验推荐剂量(RP2D)。
探索性目的:探索皮肤和血液生物标志物的变化对BEBT-305治疗中重度斑块型银屑病患者的安全性和药效学之指导意义。
[Translation] Clinical trials in healthy volunteers:
Primary objectives: To evaluate the safety and tolerability of BEBT-305 in healthy volunteers; To evaluate the pharmacokinetic characteristics of BEBT-305 in healthy volunteers; To evaluate the effect of food on the pharmacokinetics of BEBT-305.
Clinical trials in patients with moderate to severe plaque psoriasis:
Primary objectives: To evaluate the safety and tolerability of BEBT-305 in patients with moderate to severe plaque psoriasis. Secondary objectives: To evaluate the pharmacokinetic characteristics of BEBT-305 in patients with moderate to severe plaque psoriasis; To explore the effective dose of BEBT-305 for the treatment of patients with moderate to severe plaque psoriasis, i.e. the recommended dose (RP2D) for Phase II clinical trials.
Exploratory objectives: To explore the guiding significance of changes in skin and blood biomarkers on the safety and pharmacodynamics of BEBT-305 in the treatment of patients with moderate to severe plaque psoriasis.