Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07493551
Eligibility Criteria:
Inclusion Criteria:
* 18 to 65 years old (including 18 and 65 years old).
* Patients diagnosed with schizophrenia (by ICD-10 criteria) before screening.
* Weight: male patients with weight ≥50.0 kg, female patients with weight ≥45.0 kg, with the body mass index of 19.0\~35.0 kg/m\^2 (including 19.0 and 35.0).
* Positive and Negative Syndrome Scale (PANSS) total score lower than 70 at screening and baseline.
* Clinical Global Impression-Severity (CGI-S) lower than 4 at screening and baseline.
* Patients and their guardians voluntarily sign the ICF and are able to comply with the requirements of the study.
Exclusion Criteria:
* Be allergic, or have a clear history of allergies to trial drugs and components.
* Patients with cardiovascular, liver, kidney, gastrointestinal, psychiatric, or neurological diseases that may affect participation in the trial, as determined by the investigator.
* History of tardive dyskinesia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07493551
Study Brief:
Protocol Section:
NCT07493551