[Translation] A single-dose, dose-escalation Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of YJH-012 injection in healthy Chinese adult male participants and patients with hyperuricemia
主要目的:评估YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药的安全性和耐受性。
次要目的:1.评估YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药的药代动力学(PK)特征。2.评估YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药的药效学(PD)特征。3.评估YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药的免疫原性(ADA)。
探索性目的:1.探索YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药后血浆及尿液中的主要代谢产物。2.探索YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药后尿液中的排泄特征。3.探索YJH-012在成年男性健康参与者和高尿酸血症患者中单次给药后对QT间期的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of a single dose of YJH-012 in healthy adult male participants and patients with hyperuricemia.
Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of a single dose of YJH-012 in healthy adult male participants and patients with hyperuricemia. 2. To evaluate the pharmacodynamic (PD) characteristics of a single dose of YJH-012 in healthy adult male participants and patients with hyperuricemia. 3. To evaluate the immunogenicity (ADA) of a single dose of YJH-012 in healthy adult male participants and patients with hyperuricemia.
Exploratory objectives: 1. To explore the main metabolites of YJH-012 in plasma and urine after a single dose in healthy adult male participants and patients with hyperuricemia. 2. To explore the excretion characteristics of YJH-012 in urine after a single dose in healthy adult male participants and patients with hyperuricemia. 3. To explore the effect of YJH-012 on the QT interval after a single dose in healthy adult male participants and patients with hyperuricemia.