Schizophrenia Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of JX11502MA Capsules in Patients With Schizophrenia.
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
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. ;
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