Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432738
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-24
Brief Title:
ZL-82 Double-blind Clinical Trial
Sponsor:
Chengdu Zenitar Biomedical Technology Co Ltd
Organization:
Chengdu Zenitar Biomedical Technology Co Ltd
Study Overview
Official Title:
A Single-center Randomized Double-blind Placebo-controlled Dose-escalation Design to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and QTc Effect Research
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 Janus kinase 3 JAK3 developed by Chengdu Xiuling Biomedical Technology Co Ltd According to Document No 44 of 2020 Chemical Drug Registration Classification and Application Document Requirements it belongs to Category 1 chemical drugs and is an innovative drug that has not been marketed at home or abroad
ZL-82 tablets have completed non-clinical pharmacology non-clinical PK and toxicology experiments and have obtained the first-in-human randomized double-blind placebo-controlled dose-increasing dose-increasing approval for single oral administration of ZL-82 tablets Partial results of the phase I clinical study on safety tolerability pharmacokinetics and preliminary pharmacodynamics It is necessary to further explore the safety tolerability pharmacokinetics and pharmacodynamic characteristics of multiple administrations based on the results obtained from the first human trial
Non-clinical in vitro hERG tests and in vivo animal safety pharmacology tests of ZL-82 tablets showed no relevant cardiac safety concerns According to the ICH E14 guideline Clinical Evaluation of QTQTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs Evaluation2 it is recommended to conduct cardiac safety evaluation of experimental drugs with systemic bioavailability to evaluate the impact of experimental drugs on cardiac safety This evaluation should include evaluation of the effect of the new drug on the QTQTc interval and collection of adverse cardiovascular events Establishing a relationship between ZL-82 drug concentration and QTQTc interval changes will provide additional information for the analysis of cardiac repolarization trial planning and interpretation to facilitate analysis of the effects of drugs on QTQTc interval changes Concentration-response analysis used to characterize the effect of the test drug on the QTQTc interval can be used as an alternative to time point analysis
This study will evaluate the safety tolerability pharmacokinetics and pharmacodynamic characteristics of ZL-82 tablets in singlemultiple oral doses in healthy subjects and will also evaluate the effect of ZL-82 tablets on QTc
ZL-82 tablets have completed non-clinical pharmacology non-clinical PK and toxicology experiments and have obtained the first-in-human randomized double-blind placebo-controlled dose-increasing dose-increasing approval for single oral administration of ZL-82 tablets Partial results of the phase I clinical study on safety tolerability pharmacokinetics and preliminary pharmacodynamics It is necessary to further explore the safety tolerability pharmacokinetics and pharmacodynamic characteristics of multiple administrations based on the results obtained from the first human trial
Non-clinical in vitro hERG tests and in vivo animal safety pharmacology tests of ZL-82 tablets showed no relevant cardiac safety concerns According to the ICH E14 guideline Clinical Evaluation of QTQTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs Evaluation2 it is recommended to conduct cardiac safety evaluation of experimental drugs with systemic bioavailability to evaluate the impact of experimental drugs on cardiac safety This evaluation should include evaluation of the effect of the new drug on the QTQTc interval and collection of adverse cardiovascular events Establishing a relationship between ZL-82 drug concentration and QTQTc interval changes will provide additional information for the analysis of cardiac repolarization trial planning and interpretation to facilitate analysis of the effects of drugs on QTQTc interval changes Concentration-response analysis used to characterize the effect of the test drug on the QTQTc interval can be used as an alternative to time point analysis
This study will evaluate the safety tolerability pharmacokinetics and pharmacodynamic characteristics of ZL-82 tablets in singlemultiple oral doses in healthy subjects and will also evaluate the effect of ZL-82 tablets on QTc
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None