[Translation] A Phase I clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of HS-20118 after single and multiple oral escalating doses and the effect of food on pharmacokinetics in adult subjects
主要研究目的:
1.SAD研究:在健康受试者中评估HS-20118单次口服给药剂量递增后的安全性和耐受性;
2.MAD研究:在中重度斑块状银屑病患者中评估HS-20118多次口服给药剂量递增后的安全性和耐受性;
次要研究目的:
1.SAD研究:在健康受试者中评估HS-20118单次口服给药剂量递增后的药代动力学(PK)特征及免疫原性特征;
2.MAD研究:在中重度斑块状银屑病患者中评估HS-20118多次口服给药剂量递增后的有效性、药代动力学(PK)特征及免疫原性特征;
探索性研究目的:
1.SAD研究:在健康受试者中评估HS-20118单次口服给药剂量递增后的药效学(PD)特征;
2.SAD研究:评价HS-20118的食物效应。
3.MAD研究:在中重度斑块状银屑病患者中评估HS-20118多次口服给药剂量递增后的药效学(PD)特征。
[Translation] Main study objectives:
1. SAD study: To evaluate the safety and tolerability of HS-20118 after single oral dose escalation in healthy subjects;
2. MAD study: To evaluate the safety and tolerability of HS-20118 after multiple oral dose escalation in patients with moderate to severe plaque psoriasis;
Secondary study objectives:
1. SAD study: To evaluate the pharmacokinetic (PK) characteristics and immunogenicity characteristics of HS-20118 after single oral dose escalation in healthy subjects;
2. MAD study: To evaluate the efficacy, pharmacokinetic (PK) characteristics and immunogenicity characteristics of HS-20118 after multiple oral dose escalation in patients with moderate to severe plaque psoriasis;
Exploratory study objectives:
1. SAD study: To evaluate the pharmacodynamic (PD) characteristics of HS-20118 after single oral dose escalation in healthy subjects;
2. SAD study: To evaluate the food effect of HS-20118.
3. MAD study: To evaluate the pharmacodynamic (PD) characteristics of HS-20118 after multiple oral escalating doses in patients with moderate to severe plaque psoriasis.