Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals

Korábbi kezelés

• Has previously received antiviral therapy (ART) or has been vaccinated against HIV.

Más betegség

• Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies).
• A history of severe disease or the presence of other severe chronic conditions.
• A history of mental health disorders or a family history of psychiatric diseases.

Laborértékek

• Any of the Following Conditions:
  • 1）Persistent unexplained fever above 38°C within 1 month prior to screening or during the screening phase.
  • 2）Persistent diarrhea (more than 3 bowel movements per day) within 1 month prior to screening or during the screening phase.
  • 3）Severe infections, opportunistic infections, or sepsis within 6 months prior to screening or during the screening phase.
  • 6、Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
  • 7、Abnormal 12-lead electrocardiogram (ECG) findings with clinical significance at screening, such as a male QTcF interval (Fridericia correction formula) \> 450 ms, or female QTcF \> 470 ms.
  • 8、Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 times the upper limit of normal (ULN), or total bilirubin \> 1.5 times ULN at screening.
  • 9、Serum creatinine clearance (Ccr) \< 60 mL/min at screening (calculated using the Cockcroft-Gault formula).
  • 10、Known or suspected history of drug abuse (including morphine, methamphetamine, ketamine, dimethylthioamphetamine, tetrahydrocannabinolic acid, cocaine), or a positive baseline drug screening test.
  • 11、A history of alcohol abuse within the past year (defined as consuming more than 14 standard units of alcohol per week, where 1 standard unit is 14 g of alcohol, equivalent to 360 mL of 5% beer, 45 mL of 40% liquor, or 120 mL of 12% wine), or inability to comply with the study's alcohol prohibition during the study.
  • 12、Smoking more than 5 cigarettes per day within the last 3 months prior to screening, or inability to comply with the study's smoking prohibition during the study.
  • 13、Receiving any vaccine within 3 months prior to screening, or planning to receive any vaccine during the study.
  • 14、Received any investigational drug treatment or participated in any drug/device trial (excluding in vitro diagnostic devices) within 3 months prior to dosing.
  • 15、Major surgery within 30 days prior to dosing, or planned major surgery during the study.
  • 16、Blood donation or loss of ≥ 400 mL within 3 months prior to screening, or receiving a blood transfusion during this period.
  • 17、Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.

• The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments.
• At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female.
• At the time of screening, male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg.
• Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL.
• For Female Subjects: Only non-reproductive females will be included, which includes those who have undergone surgical sterilization (documented hysterectomy or bilateral oophorectomy) at least 6 weeks prior to the screening visit, or those who have been postmenopausal for at least 12 months (confirmed by a follicle-stimulating hormone (FSH) level ≥40 IU/L).
• For Male Subjects with Fertile Female Partners: The subject must agree to use a non-pharmacological contraception method for 14 days prior to dosing, during the study, and for 3 months following the administration of the study drug. Male subjects must not donate sperm during this period.
• The subject must be willing to adhere to the study protocol, including visits, study treatment, laboratory tests, and other study-related procedures and requirements.