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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
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MechanismMitochondrial proteins stimulants |
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Drug Highest PhaseDiscontinued |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价DH001片预防肿瘤患者使用阿霉素治疗后发生心脏毒性的随机、双盲、安慰剂平行对照的多中心临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy of DH001 tablets in preventing cardiac toxicity in cancer patients treated with doxorubicin
1. 初步评估DH001对于肿瘤患者使用阿霉素后发生心脏毒性的预防效果;
2. 探索合适的用药剂量,为后续确证性研究的用药剂量提供依据;
3. 评估DH001对于阿霉素治疗肿瘤患者的疗效影响;
4. 评估DH001在经阿霉素治疗的肿瘤患者中的安全性。
[Translation] 1. Preliminary evaluation of the effect of DH001 in preventing cardiac toxicity in cancer patients after using doxorubicin;
2. Explore the appropriate dosage to provide a basis for the dosage of subsequent confirmatory studies;
3. Evaluate the effect of DH001 on the efficacy of doxorubicin in cancer patients;
4. Evaluate the safety of DH001 in cancer patients treated with doxorubicin.
评价DH001在健康成年受试者单次及多次口服给药后的安全性、耐受性、药代动力学的Ⅰ期临床试验
[Translation] Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of DH001 after single and multiple oral administration in healthy adult subjects
本试验分为 2 项研究开展, 每项研究试验目的如下:
研究 1:
主要目的: 评价DH001 单次口服给药后的安全性和耐受性。
次要目的: 评价DH001 单次口服给药后的药代动力学特征。
研究 2:
主要目的: 评价DH001 多次口服给药后的安全性和耐受性。
次要目的: 评价DH001 多次口服给药后的药代动力学特征。
[Translation] This trial was divided into 2 studies, and the purpose of each study is as follows:
Study 1:
Primary purpose: To evaluate the safety and tolerability of DH001 after a single oral administration.
Secondary purpose: To evaluate the pharmacokinetic characteristics of DH001 after a single oral administration.
Study 2:
Primary purpose: To evaluate the safety and tolerability of DH001 after multiple oral administration.
Secondary purpose: To evaluate the pharmacokinetic characteristics of DH001 after multiple oral administration.
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