Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease

Prior treatment

• Subjects who have experienced a New York Heart Association (NYHA) Class III or above congestive heart failure, unstable angina pectoris, acute myocardial infarction, hemorrhagic stroke (stroke), and ischemic stroke (including transient ischemic attack) within 6 months before screening; or those who have undergone any percutaneous coronary intervention or coronary artery bypass grafting, heart valve repair/replacement; or those with severe arrhythmia as judged by the investigator at the time of screening;
• Atypical PD (e.g., Parkinsonism, multiple system atrophy, progressive supranuclear palsy), or secondary PD (e.g., delayed or drug-induced PD);
• Subjects who have taken any serotonin reuptake inhibitors (such as fluoxetine, paroxetine, trazodone, citalopram, escitalopram, etc.) within 4 weeks prior to screening;
• Subjects who have a history of surgical treatment for PD (e.g., deep brain stimulation, pallidotomy, etc.), or those who have undergone any major or medium surgery or have experienced any serious trauma or serious infection within 3 months prior to screening, those who are unsuitable for this study at the discretion of the investigator or plan to undergo any surgical treatment (excluding an outpatient surgery that has no impact on subject safety or study results as judged by the investigator) during the study;
• Subjects who have participated in a clinical trial that involves the administration of an investigational drug (a new chemical entity), device, or surgery within 3 months or 5 half-lives before screening, whichever is longer;
• Subjects with evidence of alcoholism (≥ 14 units of alcohol per week on average, 1 unit ≈ 360 mL of beer, 45 mL of liquor, or 150 mL of wine) or drug abuse within 6 months prior to screening that may interfere with the subject\'s understanding of the study or completion of the study as judged by the investigator;
• Subjects who are known to have hypersensitivity/allergic reaction or intolerance to any component of the investigational product;
• Subjects who have donated or lost blood of ≥400 mL, or received blood transfusions within 3 months prior to screening;

Other illness

• Presence of any medical condition that may interfere with full participation in the study, including but not limited to the following: medical history of epilepsy or any complications, medical history of hemolytic anemia, pulmonary embolism, respiratory depression, active psychiatric disease, or malignancy;
• Subjects with unstably controlled hypertension at screening, defined as the systolic blood pressure ≥ 160 mmHg and/or the diastolic blood pressure ≥ 100 mmHg (verify before randomization);
• Any condition (e.g., severe arthritis, severe dyskinesia, traumatic injury with permanent physical disability) that may affect the MDS-UPDRS motor examination;
• Subjects who have a history of suicidal intention (including actual attempts, interrupted attempts, or failed attempts) and are at risk of committing suicide as judged by the investigator;
• Subjects who have dementia or moderate or above cognitive dysfunction and the MDS-UPDRS score for 1.1 cognitive impairment is ≥ 3 at screening;
• Positive for any of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and Treponema pallidum antibody (TP-Ab) at screening;
• Subjects who are unable to swallow oral drugs, or have any condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any condition that may pose a hazard to subjects participating in the study, as judged by the investigator;
• Subjects who have a history of organ transplantation (excluding corneal transplantation);
• Subjects who have any other conditions that may affect study compliance as deemed by the investigator, or those who are unable to participate in the study for their own reasons.

Lab values

• Subjects with prior personal or family history of long-QT syndrome, family history of sudden death of any immediate family members (meaning a parent, child, or sibling) prior to the age of 40 years; and/or personal history of unexplained syncope within 1 year prior to screening; and/or QTcF \> 450 ms (male), QTcF \> 470 ms (female) measured by Electrocardiogram(ECG) at rest during screening;
• Subjects who have clinically significant hepatic insufficiency which is defined as the total bilirubin (TBIL) \> 2 × upper limit of normal (ULN) or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2 × ULN;
• Subjects who have clinically significant renal insufficiency (creatinine clearance \[Ccr\] \< 30 mL/min, see the calculation formula in Appendix II);

Other

• Subjects with symptomatic orthostatic hypotension at screening, or who experiences a decrease in systolic blood pressure of ≥ 30 mmHg or a decrease in diastolic blood pressure of ≥ 15 mmHg within 3 minutes when changing from the supine to the standing position (verify before randomization);
• Subjects who suffer from severe mental abnormalities (anxiety, depression) as judged by the investigator, and the depression or anxiety score as rated by the Part I of the MDS-UPDRS is ≥ 3 at screening;
• Pregnant or breastfeeding women;

• Subjects who voluntarily participate in the clinical trial, and have signed the informed consent form (ICF), are able to understand and follow the study protocol, willing to visit the study site on time, fully understand the content, process and potential adverse reactions of the study, and indicate the date of signing the ICF;
• Males or females aged 30-80 years (both inclusive) at the time of signing the ICF;
• Subjects who are diagnosed with PD according to the Diagnostic Criteria for Parkinson's Disease in China (2016 edition);
• The scores of modified Hoehn and Yahr Scale at screening are 1-2.5 (both inclusive);
• Subjects who have not previously received anti-PD drugs; or those who have previously used any anti-PD drugs but have not received such drug within 4 weeks before study entry; or those who have received the anti-PD drug at a stable dose for at least 4 weeks before study entry and agree to maintain the original treatment regimen during the study;
• Subjects with the scores of MDS-UPDRS Part III of ≥ 22 at screening (it should be scored ≥ 12 hours apart from the most recent dose of the anti-PD drug for subjects who have been receiving an anti-PD drug at a stable dose for at least 4 weeks prior to study entry);
• Subjects of childbearing potential (including spouses of male subjects) who have no childbearing or sperm donation plan from the end of the screening period to within 6 months after the last dose and are willing to use at least one effective method (see Appendix I for details) for contraception.