Phase I Trial of HHK101 in Patients With Schizophrenia

Inclusion criteria

• Voluntarily provide written informed consent by the participant and his/her legal representative;
• Aged 18-65 years, weight ≥ 45 kg, body mass index 19-35 kg/m², male or female;
• Diagnosed with stable schizophrenia, with 1 antipsychotic agent at a stable dose for ≥ 4 weeks before screening;
• Positive and Negative Syndrome Scale (PANSS) total score ≤ 80, with each positive sub-scale item score < 5.

Exclusion criteria

• history of allergies to ≥3 different substances, or active allergic disease;
• Past history of neuroleptic malignant syndrome or with current medical conditions including heart failure, acute coronary syndrome, stroke, orthostatic hypotension, dementia, Parkinson's disease, epilepsy, tardive dyskinesia, etc;
• Received any investigational product within 12 weeks before screening;
• Received strong/moderate inhibitors or inducers of CYP3A4 or CYP2D6 enzymes, or traditional Chinese medicines within 1 week before dosing;
• Pregnant or lactating, or with a positive pregnancy test;
• With plan for pregnancy, sperm/ovum cryopreservation or donation, and refuse to use effective contraception from screening through 6 months after last dosing;
• With white blood cell ≤ 3 × 10⁹/L; neutrophil ≤ 1 × 10⁹/L; platelet ≤ 80 × 10⁹/L; hemoglobin ≤ 80 g/L; ALT ≥ 2 × ULN; AST ≥ 2 × ULN; total bilirubin ≥ 1.5 × ULN; CK ≥ 3 × ULN; serum creatinine ≥ 1.5 × ULN; triglycerides ≥ 3.0 mmol/L; glycated hemoglobin (HbA1c) ≥ 7.5 %; systolic blood pressure ≥ 160 mmHg or ≤ 90 mmHg; diastolic blood pressure ≥ 100 mmHg or ≤ 60 mmHg; heart rate ≤ 50 bpm or ≥ 110 bpm; QTcF > 470 ms (female) / > 450 ms (male); FT4 outside reference range; positive hepatitis B surface antigen; positive hepatitis C antibody; positive HIV antibody; positive syphilis serology test;
• Other conditions unsuitable for the trial judged by the investigator.