Qilu Pharmaceutical Initiates Phase I Clinical Trial of QLM2012 for Adult Schizophrenia

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd. has initiated a Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of QLM2012 in healthy Chinese adults and schizophrenia patients following single-dose administration. The clinical trial registration number is CTR20253584, with the initial information disclosure date on September 4, 2025.

The drug formulation is an injection, administered via intramuscular injection. Five dosing groups ranging from 20mg to 240mg have been established, with an initial dose of 20mg. Subsequent dose escalation will be determined based on obtained study results to decide whether dose adjustments are necessary. The dosing regimen consists of a single administration. The primary objective of this trial is to evaluate the safety and tolerability of QLM2012 following a single dose in healthy Chinese adults and schizophrenia patients; additionally, the pharmacokinetic characteristics after a single dose will be assessed.

QLM2012 is a chemical drug indicated for adult schizophrenia. Schizophrenia is a severe mental disorder with symptoms including hallucinations, delusions, and disorganized thinking. Diagnosis is primarily based on symptom presentation and psychiatric evaluation, with treatment mainly involving medication, combined with psychological and social support.

The primary endpoint indicators of this trial include adverse events/severe adverse events, injection site reactions, laboratory tests, physical examinations, 12-lead electrocardiogram, vital signs, weight, and scale assessments; secondary endpoint indicators include pharmacokinetic parameters (Tmax, Cmax, AUC0-t, AUC0-∞, λZ, CL/F, Vd/F, and t1/2, etc.).

Currently, the experiment is in progress (not yet recruiting), with a target enrollment of 42 participants.

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