[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous dose of ZKLJ02 for injection in Chinese health study participants
主要目的:评价注射用 ZKLJ02 在中国健康研究参与者中单次静脉给药的安全性和耐受性。
次要目的:
(1) 评价注射用 ZKLJ02 在中国健康研究参与者中单次静脉给药的药代动力学(PK)特征;
(2) 评价注射用 ZKLJ02 在中国健康研究参与者中单次静脉给药的药效动力学(PD)特征;
(3) 评价注射用 ZKLJ02 在中国健康研究参与者中单次静脉给药的免疫原性。
(4) 初步探索 PK/PD 相关性。
[Translation] Primary objective: To evaluate the safety and tolerability of a single intravenous administration of ZKLJ02 for injection in Chinese health research participants.
Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of a single intravenous administration of ZKLJ02 for injection in Chinese health research participants;
(2) To evaluate the pharmacodynamic (PD) characteristics of a single intravenous administration of ZKLJ02 for injection in Chinese health research participants;
(3) To evaluate the immunogenicity of a single intravenous administration of ZKLJ02 for injection in Chinese health research participants.
(4) To preliminarily explore the PK/PD correlation.