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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
评价ND-003片在健康成年志愿者中单、多次给药的安全性、耐受性、药代动力学特征以及食物影响的Ⅰ期临床研究
[Translation] Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and food effects of single and multiple doses of ND-003 tablets in healthy adult volunteers
1、评估健康成年志愿者单次/多次口服ND-003片的安全性及耐受性。
2、评估健康成年志愿者单次/多次口服ND-003片的药代动力学特征。
3、评价食物对健康成年志愿者单次口服ND-003片药代动力学的影响。
[Translation] 1. Evaluate the safety and tolerability of single/multiple oral administration of ND-003 tablets in healthy adult volunteers.
2. Evaluate the pharmacokinetic characteristics of single/multiple oral administration of ND-003 tablets in healthy adult volunteers.
3. Evaluate the effect of food on the pharmacokinetics of single oral administration of ND-003 tablets in healthy adult volunteers.
A Single-arm, Non-randomized, Open-label, Dose-escalation and Dose-expansion, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles, as Well as Preliminary Efficacy, of ND-003 in Chinese Patients With Advanced Solid Tumors.
This study is done to test the safety and preliminary efficacy of drug ND-003 tablets in patients with solid tumors. ND-003 is a highly potent and selective small molecular inhibitor of NTRK (neurotrophic receptor tyrosine kinase) and RET (rearranged during transfection). The study also investigates how the drug is absorbed and processed in the human body.
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