[Translation] A randomized, double-blind, placebo-controlled, single-dose escalation phase I clinical study to evaluate the safety and tolerability of F012 in patients with hyperuricemia with or without gout
主要研究目的:
评估F012在高尿酸血症伴或不伴痛风患者中单次给药的安全性和耐受性。
次要研究目的:
评估F012在高尿酸血症伴或不伴痛风患者中单次给药的药代动力学特征;
评估F012在高尿酸血症伴或不伴痛风患者中单次给药的药效学特征;
评估F012在高尿酸血症伴或不伴痛风患者中单次给药的免疫原性。
探索性研究目的:
探索F012在高尿酸血症伴或不伴痛风患者中单次给药的心脏安全性。
通过F012的群体药代动力学(Pop PK)模型,为F012后续临床研究方案提供参考。
[Translation] Main study objectives:
To evaluate the safety and tolerability of a single dose of F012 in patients with hyperuricemia with or without gout.
Secondary study objectives:
To evaluate the pharmacokinetic characteristics of a single dose of F012 in patients with hyperuricemia with or without gout;
To evaluate the pharmacodynamic characteristics of a single dose of F012 in patients with hyperuricemia with or without gout;
To evaluate the immunogenicity of a single dose of F012 in patients with hyperuricemia with or without gout.
Exploratory study objectives:
To explore the cardiac safety of a single dose of F012 in patients with hyperuricemia with or without gout.
The Pop PK model of F012 is used to provide a reference for the subsequent clinical research plan of F012.