Clinical trial NCT06560489: Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients
Official title: Clinical Trial of Safety, Pharmacodynamics and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98 in Primary Treatment of HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Hiv
Keywords: LP-98
Double-Blind
Treatment-Naive HIV-Infected Individuals
Lead sponsor: Shanxi Kangbao Biological Product Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2024-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in Treatment-Naive HIV-Infected Individuals

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-infected individuals who have not received antiviral therapy.

This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.

The study included screening period (D-28\~D-1), treatment period (D1-D57), and follow-up period (D58\~D71).

Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate in the study and obtain informed consent prior to any study-related evaluation;
2. Aged 18-65 years at the time of the screening visit (including the cut-off), male or female;
3. 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;
4. Plasma HIV RNA level ≥1000 copies /mL, CD4+T lymphocyte count ≥200 /μL;
5. 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);
6. 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;
7. Be willing to comply with visits, study treatments, laboratory tests, and other study-related procedures and requirements as specified in the study protocol.

Exclusion Criteria:

1. is allergic to the investigational drug product or its excipients, or has a history of severe allergy (including any food allergy or drug allergy);
2. have received antiviral therapy (ART), or been vaccinated against HIV;
3. Have a history of serious illness or other serious chronic diseases;
4. Have a history of mental illness, or have a family history of mental illness;
5. 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;
6. Hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (HCV-Ab) positive;
7. 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;
8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 1.5 times ULN, or total bilirubin \> 1.5 times ULN during screening;
9. Serum creatinine clearance (Ccr) at screening was \< 60 mL/min (calculated according to Cockcroft-Gault formula);
10. A known or suspected history of drug abuse (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine), or a positive baseline drug screening test;
11. 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;
12. 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;
13. have received any vaccine in the three months prior to screening, or plan to receive any vaccine during the study period;
14. received any investigational drug therapy or participated in any drug/investigational device trial within 3 months prior to dosing;
15. had undergone a major surgical procedure within 30 days prior to dosing or planned to undergo a major surgical procedure during the study period;
16. Those who have donated blood or lost blood ≥ 400 ml or received blood transfusion within 3 months before screening;
17. There are other circumstances that are not suitable for participation in this study.

Primary outcomes:
measure: Changes from baseline in respiration rate of Vital Signs.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in blood pressure of Vital Signs.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in Blood lactate of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in body temperature of Vital Signs.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in red blood cell count of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in white blood cell count of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in neutrophil count of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in lymphocyte count of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in platelet count of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in hemoglobin of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in PT of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in INR of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in APTT of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in total bilirubin of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in direct bilirubin of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in ALT of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in AST of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in total protein of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in albumin of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urea of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in creatinine of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in uric acid of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in glucose of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in potassium of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in sodium of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in chlorine of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine specific gravity of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine pH of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine glucose of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine protein of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine ketone body of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine white blood cell of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine bilirubin of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in urine occult blood of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in Electrocardiogram.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in CK of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in CK-MB of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in LDH of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in ALP of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in Triglyceride of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in CHOL of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in TP of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in ALB of Laboratory Examination
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in UA of Laboratory Examination
timeFrame: Within 71 days after the first administration.
Secondary outcomes:
measure: Changes from baseline in Immunogenic blood collection of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in HIV viral load detection of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
measure: Changes from baseline in CD4+T cell counts of Laboratory Examination.
timeFrame: Within 71 days after the first administration.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
state: Henan
Study officials:
affiliation: Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
name: Qingxia Zhao, Doctor
role: STUDY_DIRECTOR
References: