Status:
ENROLLING_BY_INVITATION
Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients
Lead Sponsor:
Shanxi Kangbao Biological Product Co., Ltd.
Collaborating Sponsors:
Chinese Academy of Medical Sciences
Conditions:
Hiv
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
A Randomized, Double-Blind, Parallel-Group, Exploratory Clinical Study to Evaluate the Safety, Pharmacodynamic Effects, and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98...
Detailed Description
This is a randomized, double-blind, parallelize-designed, multicenter, exploratory clinical study to evaluate the safety, PD, and PK profile of multiple subcutaneous injections of LP-98 in HIV-infecte...
Eligibility Criteria
Inclusion
- Voluntarily participate in the study and obtain informed consent prior to any study-related evaluation;
- Aged 18-65 years at the time of the screening visit (including the cut-off), male or female;
- At the time of screening visit, the weight of male subjects is not less than 50 kg and that of female subjects is not less than 45 kg;
- Plasma HIV RNA level ≥1000 copies /mL, CD4+T lymphocyte count ≥200 /μL;
- For female subjects: Only subjects with no reproductive potential were included, including surgical sterilization at least 6 weeks prior to the screening visit (documented hysterectomy or bilateral oopectomies), and menopause ≥12 months prior to the screening visit (menopause confirmed by follicle stimulating hormone (FSH) level ≥40IU/L);
- For male subjects with fertile female partners, consent must be given to the use of non-drug contraception for 14 days prior to dosing, during the study period, and for 3 months after dosing. Male subjects are not allowed to donate sperm during this period;
- Be willing to comply with visits, study treatments, laboratory tests, and other study-related procedures and requirements as specified in the study protocol.
Exclusion
- is allergic to the investigational drug product or its excipients, or has a history of severe allergy (including any food allergy or drug allergy);
- have received antiviral therapy (ART), or been vaccinated against HIV;
- Have a history of serious illness or other serious chronic diseases;
- Have a history of mental illness, or have a family history of mental illness;
- any of the following conditions exist: i. Unexplained persistent irregular fever above 38 °C within 1 month before or during the screening period; ii. Persistent diarrhea (more than 3 stools/day) within 1 month before or during the screening period; iii. Severe infection, opportunistic infection, or sepsis in the 6 months prior to or during the screening period;
- Hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (HCV-Ab) positive;
- The 12-lead ECG was abnormal and clinically significant during screening, such as QTcF interval (Fridericia correction) \> 450 ms in male and \> 470 ms in female;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 1.5 times ULN, or total bilirubin \> 1.5 times ULN during screening;
- Serum creatinine clearance (Ccr) at screening was \< 60 mL/min (calculated according to Cockcroft-Gault formula);
- A known or suspected history of drug abuse (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine), or a positive baseline drug screening test;
- Heavy drinking in the year before screening (drinking more than 14 standard units per week, 1 standard unit containing 14 g of alcohol, such as 5% beer 360 ml, 40% spirits 45 ml, 12% wine 120 ml); Or fail to comply with the no-alcohol policy for the duration of the study;
- Smoking more than 5 cigarettes per day in the 3 months prior to screening, or failing to comply with the no-smoking policy during the study period;
- have received any vaccine in the three months prior to screening, or plan to receive any vaccine during the study period;
- received any investigational drug therapy or participated in any drug/investigational device trial within 3 months prior to dosing;
- had undergone a major surgical procedure within 30 days prior to dosing or planned to undergo a major surgical procedure during the study period;
- Those who have donated blood or lost blood ≥ 400 ml or received blood transfusion within 3 months before screening;
- There are other circumstances that are not suitable for participation in this study.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06560489
Start Date
September 2 2024
End Date
May 20 2025
Last Update
September 19 2024
Active Locations (1)
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1
Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
Zhengzhou, Henan, China