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Clinical Trial Summary

A multicenter, randomized, double-blind, placebo-controlled, dose-increasing phase Ib/II clinical trial to evaluate the safety, tolerance and pharmacokinetic characteristics of JX11502MA capsules administered multiple times in patients with schizophrenia


Clinical Trial Description

This study adopts a multi-center, randomized, double-blind, dose-increasing, parallel-control titration drug delivery study design. Preset three dose groups (S1, S2, S3), low, medium and high, with target doses of 1.5mg, 3mg and 6mg respectively. Each dose group included 20 subjects (16 patients received the test drug and 4 patients received placebo). During the test, observe the safety and tolerance of the subjects, and collect PK blood samples. Schizophrenic patients who met the inclusion criteria after screening and evaluation were randomly enrolled on the baseline day. On the first administration day, all dose groups took 1.5mg as the starting dose. Each subject should closely observe the tolerance and safety within 24 hours after the first administration. Only when the investigator evaluated it as tolerable, can the subsequent multiple administration be continued. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06356389
Study type Interventional
Source Zhejiang Jingxin Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2, 2022
Completion date January 28, 2023

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