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Drug Highest PhasePhase 1 |
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评估中国健康成年参与者单次和多次口服QBT-006的耐受性、安全性和药代动力学特征以及食物对QBT-006药代动力学影响的I期临床试验
[Translation] Phase I clinical trial to evaluate the tolerability, safety and pharmacokinetic characteristics of single and multiple oral doses of QBT-006 in healthy Chinese adult participants and the effect of food on the pharmacokinetics of QBT-006
第一部分试验_单次给药剂量递增(SAD)试验:
主要目的:
评估健康成年参与者单次口服QBT-006的安全性和耐受性以及药代动力学特征。
初步评估高脂饮食对QBT-006药代动力学的影响。
次要目的:
初步评价单次给药QBT-006后在健康人体内的药效学指标变化,为后续临床试验设计提供依据。
第二部分试验_多次给药剂量递增(MAD)试验
主要目的:
评估健康成年参与者多次口服QBT-006的安全性和耐受性以及药代动力学特征。
次要目的:
初步评价多次给药QBT-006后在健康人体内的药效学指标变化,为后续临床试验设计提供依据。
[Translation] Part I trial_Single ascending dose (SAD) trial:
Main purpose:
To evaluate the safety, tolerability and pharmacokinetic characteristics of QBT-006 after a single oral administration in healthy adult participants.
To preliminarily evaluate the effect of a high-fat diet on the pharmacokinetics of QBT-006.
Secondary purpose:
To preliminarily evaluate the changes in pharmacodynamic indicators in healthy humans after a single administration of QBT-006, and provide a basis for the design of subsequent clinical trials.
Part II trial_Multiple ascending dose (MAD) trial
Main purpose:
To evaluate the safety, tolerability and pharmacokinetic characteristics of QBT-006 after multiple oral administration in healthy adult participants.
Secondary purpose:
To preliminarily evaluate the changes in pharmacodynamic indicators in healthy humans after multiple administrations of QBT-006, and provide a basis for the design of subsequent clinical trials.
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