Testing HHK101 for safety and dosing in schizophrenia
Tests the study drug HHK101 for safety and dosing in adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: Phase I Trial of HHK101 in Patients With Schizophrenia
Key facts
- Where
- Changsha, Huzhou, Shanghai, and Xi’an, ChinaSee the 4 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07815210, who can take part
Where in China
- Hunan Brain Hospital (The Second People's Hospital of Hunan Province)Changsha, ChinaNo longer taking part
- Huzhou No.3 People's HospitalHuzhou, ChinaNo longer taking part
- Shanghai Mental Health CenterShanghai, ChinaNo longer taking part
- Xi'an Mental Health CenterXi’an, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
- Trial code
- NCT07815210
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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: 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: 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; 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; Other conditions unsuitable for the trial judged by the investigator; 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; 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.