A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.

Korábbi kezelés

• Use of immunosuppressants or immunomodulators (e.g., thymus) within 6 months prior to the first dose Patients taking peptides or cytotoxic agents, or those who have received corticosteroid therapy (excluding topical, inhalational, or ophthalmic treatments) for at least one week within 6 months prior to the first dose, or those who have had a history of vaccination within 1 month prior to screening or have planned to receive vaccinations during the trial period;
• Prior to the first dose, the subject has received interferon or peginterferon therapy within the preceding 6 months, or plans to receive interferon or peginterferon therapy during the trial period;
• Has previously undergone organ transplantation;
• Patients with a prior history of myocarditis, pericarditis, or idiopathic cardiomyopathy;
• Having participated in other drug clinical trials and used trial drugs, or having participated in clinical trials of medical devices or vaccines, within 3 months prior to the first dose administration or within 5 drug half-life periods (whichever period is longer);
• In this trial, participants who previously participated in the single-dose trial of CPU-YL01 may be re-screened for enrollment during the multiple-dose trial phase; the time limit requirements for prior trial participation of such participants shall be consistent with the exclusion criteria specified in Clause 15.

Más betegség

• A history of liver cirrhosis (confirmed by liver biopsy), or the presence of complications such as gastroesophageal variceal bleeding, hepatic encephalopathy, or ascites, or a liver stiffness measurement>12.4 kPa during screening;
• Presence of other clinically significant liver diseases other than chronic hepatitis B, such as autoimmune hepatitis, toxic hepatitis, hemochromatosis, alcoholic liver disease, drug-induced hepatitis, α1-antitrypsin deficiency, Wilson's disease, etc.;
• Positive for hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies, or positive for Treponema pallidum (TP) antibodies with confirmatory positive results on the rapid plasma reagin (RPR) test;
• Exclusion criteria include a history of malignant tumor or recurrence within the 5 years prior to the first dose, except for specific cancers that can be cured by surgical resection (e.g., non-melanoma skin cancer, cervical intraepithelial neoplasia, thyroid tumors, breast tumors, etc., that have already been treated and show no signs of recurrence);
• Participants who, at the time of screening, suffer from systemic severe diseases affecting other organs-including but not limited to the gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, or immunological systems (including but not limited to immunodeficiency or immunosuppression), as well as psychiatric or cardiovascular and cerebrovascular diseases-and who have been determined by the study physician to be unsuitable for participation in this trial;
• Suffering from a progressive neurological disorder;
• Patients with a severe allergic constitution, a history of allergies to multiple foods or medications, or a known allergy to the test drug or its excipients;
• A history of drug use or alcohol abuse [weekly alcohol consumption exceeding 14 alcohol units (1 alcohol unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits)];

Laborértékek

• Patients with poorly controlled diabetes [fasting plasma glucose>7.0 mmol/L and/or HbA1c ≥7.5%] or hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), for whom the investigator determines that they are unsuitable to participate in this trial;
• Subjects who exhibit significant abnormalities in laboratory tests or electrocardiogram (ECG) findings during the screening phase, and whom the investigator determines to be unsuitable for participation in this trial, including but not limited to:
  • ALT or AST ≥ 2×ULN;
  • TBil ≥ 2×ULN and direct bilirubin (DBil)> 1.5×ULN;
  • Albumin <38 g/L;
  • Platelet count <125×10*9/L;
  • Absolute neutrophil count <1.5×10*9/L;
  • Prothrombin time (PT)>3s, or international normalized ratio (INR)>1.3;
  • Creatinine clearance (using the Cockcroft-Gault formula) <60 mL/min;
  • Alpha-fetoprotein (AFP)> 20 μg/L;
  • QTcF> 450 ms (men) or> 470 ms (women);

Egyéb

• Women who are pregnant or breastfeeding;
• The researchers believe that the subject is unsuitable to participate in this trial due to other reasons.

• Voluntarily sign the informed consent form (ICF), understand this study, and be willing and able to comply with and complete all trial procedures;
• Open to all genders; age range: 18-70 years(inclusive);
• The body mass index (BMI) ranges from 18 to 30 kg/m2(including the boundary values);
• Clinically diagnosed chronic hepatitis B (serum HBsAg positivity for ≥6 months; outpatient medical records, inpatient medical records, or laboratory test results may serve as evidence);
• During the screening phase, the HBsAg test result was ≤10,000 IU/mL (for participants in single-dose studies); or the HBsAg test result was ≤3,000 IU/mL (for participants in multiple-dose studies);
• Patients currently receiving a stable dose of monotherapy or combination therapy with one or two nucleos(t)ide analogs for hepatitis B virus (HBV) treatment are required to have had no changes in their nucleos(t)ide analog regimen during the preceding 6 months, and no plans to alter their nucleos(t)ide analog regimen during the trial period. The eligible treatment options are limited to the following five agents: tenofovir alafenamide fumarate (TAF), teltenofovir mesylate (TMF), tenofovir disoproxil fumarate (TDF), prafenomide mesylate tablets (formerly known as paradenomide mesylate tablets; brand name: Xinshumu), or entecavir (ETV);
• The HBV DNA test result during the screening phase was negative (below the lower detection limit of the local research center);
• Male trial participants and female trial participants of childbearing age shall agree to use effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose.