Phase I Trial of HHK101 in Patients With Schizophrenia

A Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of HHK101 in Patients With Schizophrenia

This study aims to learn how the study drug is absorbed by the body, check for possible side effects, and see if the drug may help improve symptoms 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.