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评价注射用 GMDTC 在镉超标人群中的安全性和有效性的随机、双盲、单中心、安慰剂
对照的Ⅱa 期临床研究
[Translation] A randomized, double-blind, single-center, placebo-controlled phase IIa clinical study to evaluate the safety and efficacy of GMDTC for injection in people with excessive cadmium levels
主要目的:评价注射用 GMDTC 给药后在镉超标人群中的药效动力学特征;次要目的:评价注射用 GMDTC 在镉超标人群中多次给药的安全性、耐受性及药代动力学特征;探索性目的:评价与安慰剂相比,注射用 GMDTC 在镉超标人群中肾脏功能早期损伤的改善。
[Translation] Primary objective: To evaluate the pharmacodynamic characteristics of GMDTC for injection in people with excessive cadmium levels after administration; Secondary objective: To evaluate the safety, tolerability and pharmacokinetic characteristics of GMDTC for injection after multiple administration in people with excessive cadmium levels; Exploratory objective: To evaluate the improvement of early renal function damage in people with excessive cadmium levels by GMDTC for injection compared with placebo.
Phase Ib Clinical Study on the Safety, Tolerability and Pharmacokinetic Characteristics of GMDTC for Injection After Repeated Administration in People With Excessive Cadmium Levels
This trial is a randomized, double-blind, single-center, single-dose escalating Phase I clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of GMDTC for injection after repeated administration in people with excessive cadmium levels.
注射用GMDTC在镉超标人群中多次给药的安全性、耐受性和药代动力学特征Ⅰb期临床研究
[Translation] Phase Ib clinical study on the safety, tolerability and pharmacokinetic characteristics of multiple administrations of GMDTC for injection in people with excessive cadmium levels
主要目的:评价注射用GMDTC在镉超标人群中多次给药的安全性和耐受性;
次要目的:评价注射用GMDTC在镉超标人群中多次给药的药代动力学特征和药效动力学特征。
[Translation] Primary purpose: To evaluate the safety and tolerability of multiple administrations of GMDTC for injection in people with excessive cadmium levels;
Secondary purpose: To evaluate the pharmacokinetic and pharmacodynamic characteristics of multiple administrations of GMDTC for injection in people with excessive cadmium levels.
100 Clinical Results associated with Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
100 Deals associated with Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.