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According to the Drug Clinical Trial Registration and Information Disclosure Platform, on 2024-11-26, Hangzhou MindRank Ltd. officially launched a Phase I clinical trial (CTR20244449) for MDR-001 tablets, aiming to evaluate the mass balance of a single oral dose of MDR-001 in healthy adult male subjects. The ethical review of this study was approved by the First Affiliated Hospital of Soochow University on November 13 this year.

Figure 1. Screenshot of the clinical trial

About the Trial
The clinical trial approved this time for MindRank is expected to enroll 10 participants, who will receive a 120 mg (approximately 150 μCi) oral dose of MDR-001 in a fasting state, ensuring the entire dose is taken within 10 minutes, with continuous dosing for 7 days.
The primary endpoints of this clinical trial include the cumulative excretion rate of total radioactivity in urine and feces at 168 hours, the main metabolites of MDR-001 in plasma, urine, and feces, total radioactivity in whole blood and plasma, and pharmacokinetic (PK) parameters of total radioactivity in plasma.
The secondary endpoint was to measure the PK parameters of MDR-001 in plasma; safety endpoints included: adverse events (AE), serious adverse events (SAE), physical examinations, vital signs, 12-lead electrocardiogram (ECG), laboratory tests, etc.
Table 1. Primary and Secondary Endpoint Indicators of the Trial

About MDR-001
MDR-001 is a β-arrestin 2 highly selective GLP-1 small molecule agonist independently developed by MindRank. It retains the islet cell repair and protection functions brought by β-arrestin recruitment while avoiding the side effects caused by β-arrestin 1 recruitment, such as restricted insulin secretion and mediated endocytic desensitization.
According to the preclinical studies of MDR-001, it has demonstrated excellent in vivo and in vitro efficacy and drug-like properties (including significantly improved PK and safety window). Currently, MDR-001 has been efficiently advanced to Phase IIb clinical trials, and multiple oncology and metabolic drugs are undergoing IND-enabling studies.
| References
[1] China Drug Clinical Trial and Information Disclosure Platform Official Website. From http://www.chinadrugtrials.org.cn/index.html.
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