[Translation] A single-center, randomized, double-blind, placebo-controlled, active-drug-controlled, dose-escalation phase I clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of a single dose of KL0011034 injection in healthy subjects.
主要研究目的:
在健康受试者中评价KL0011034注射液单次给药后的安全性和耐受性。
次要研究目的:
在健康受试者中评价KL0011034注射液单次给药后的药代动力学特征;
评价KL0011034注射液在人体内的药物代谢转化。
探索性研究目的:
在健康受试者中评价KL0011034注射液单次给药后的药效学特征,初步探索剂量-暴露-效应之间的关系;
探索血药浓度和QTc间的关系。
[Translation] Primary Study Objective: To evaluate the safety and tolerability of KL0011034 injection after a single dose in healthy subjects.
Secondary Study Objectives: To evaluate the pharmacokinetic characteristics of KL0011034 injection after a single dose in healthy subjects; to evaluate the drug metabolism and transformation of KL0011034 injection in humans.
Exploratory Study Objectives: To evaluate the pharmacodynamic characteristics of KL0011034 injection after a single dose in healthy subjects, and to preliminarily explore the dose-exposure-effect relationship; to explore the relationship between plasma drug concentration and QTc.