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Drug Highest PhasePhase 2 |
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评价ALT001 在中国健康受试者中单、多次给药安全性、耐受性的随机、双盲、安慰剂对照,I 期临床研究。
[Translation] A randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety and tolerability of ALT001 with single and multiple doses in healthy Chinese subjects.
观察单次和多次给予不同剂量ALT001对中国健康受试者的安全性;
探索最大耐受剂量(MTD)和后续研究推荐剂量(RD);
探索细胞因子和免疫功能改变。
[Translation] To observe the safety of single and multiple administrations of different doses of ALT001 in healthy Chinese subjects; to explore the maximum tolerated dose (MTD) and recommended dose (RD) for subsequent studies; and to explore alterations in cytokines and immune function.
/ RecruitingNot ApplicableIIT A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Doses of ALT001 in Healthy Chinese Subjects
ALT001在肌萎缩侧索硬化症患者中安全性和初步有效性的剂量递增,随机,双盲安慰剂对照,Ⅰ期临床研究。
[Translation] A dose-escalation, randomized, double-blind, placebo-controlled, phase I clinical study of the safety and preliminary efficacy of ALT001 in patients with amyotrophic lateral sclerosis (ALS).
主要目的:观察单次和连续给予不同剂量ALT001对肌萎缩侧索硬化症(ALS)患者的安全性;探索最大耐受剂量(MTD);探索后续研究推荐剂量(RD)。次要目的:探索与药物疗效相关的生物标志物;初步观察ALT001治疗肌萎缩侧索硬化症的疗效。
[Translation] Primary objective: To observe the safety of single and continuous administration of different doses of ALT001 in patients with amyotrophic lateral sclerosis (ALS); to explore the maximum tolerated dose (MTD); and to explore the recommended dose (RD) for subsequent studies. Secondary objective: To explore biomarkers related to drug efficacy; and to preliminarily observe the efficacy of ALT001 in the treatment of amyotrophic lateral sclerosis.
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