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

Phase 2RecruitingNCT07433387

Shanxi Kangbao Biological Product Co., Ltd.30 enrolled

Overview

An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 for Injection in Antiretroviral Therapy-Naive HIV-Infected Individuals

The study utilizes a sequential cohort design, with three dosage cohorts (20 mg, 40 mg, 80 mg). The cohorts will be enrolled sequentially from low to high doses, with the next dose group initiating subject screening and enrollment after the last subject in the previous cohort has been enrolled. The study plans to enroll a total of 30 subjects, with 10 subjects in each cohort. Enrolled subjects will receive LP-98 treatment at doses of 20 mg, 40 mg, or 80 mg according to their assigned cohort. The drug will be administered via subcutaneous injection, with an interval of 14 days between doses, for a total of 4 doses. The study includes a screening phase (D-28 to D-1), a treatment phase (D1 to D57), and a follow-up phase (D58 to D71). The total duration of participation for each subject is approximately 99 days.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

LP-98 20 mgDRUG

The study plans to enroll a total of 30 subjects, with 10 subjects in each cohort. Enrolled subjects will receive LP-98 treatment at doses of 20 mg, 40 mg, or 80 mg according to their assigned cohort. The drug will be administered via subcutaneous injection, with an interval of 14 days between doses, for a total of 4 doses.

LP-98 40 mgDRUG

LP-98 40 mg

LP-98 80 mgDRUG

LP-98 80 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments. 2. At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female. 3. At the time of screening, male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg. 4. Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL. 5. 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). 6. 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. 7. The subject must be willing to adhere to the study protocol, including visits, study treatment, laboratory tests, and other study-related procedures and requirements. Exclusion Criteria: 1. Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies). 2. Has previously received antiviral therapy (ART) or has been vaccinated against HIV. 3. A history of severe disease or the presence of other severe chronic conditions. 4. A history of mental health disorders or a family history of psychiatric diseases. 5. 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.

Locations (1)

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Plasma HIV RNA levels (log10 copies/mL) and changes from baseline

Changes of HIV viral load detection will be recorded.

Time frame: Within 71 days after the first administration.

Proportion of subjects with plasma HIV RNA < 50 copies/mL

Changes of HIV viral load detection will be recorded.

Time frame: Within 71 days after the first administration.

Proportion of subjects with plasma HIV RNA < 200 copies/mL

Changes of HIV viral load detection will be recorded.

Time frame: Within 71 days after the first administration.

Absolute CD4+ T lymphocyte count and change from baseline

Changes of CD4+T counts will be recorded.

Time frame: Within 71 days after the first administration.

CD4+/CD8+ T lymphocyte ratio and change from baseline

Changes of CD4+/CD8+ T counts will be recorded.

Time frame: Within 71 days after the first administration.

Secondary Outcomes

Changes from baseline in respiration rate of Vital Signs.

Respiration rate in times / minute

Time frame: Within 71 days after the first administration.

Changes from baseline in blood pressure of Vital Signs.

Blood pressure in mmHg

Time frame: Within 71 days after the first administration.

Changes from baseline in Blood lactate of Laboratory Examination.

Central Contacts

Yuxian He, Doctor

CONTACT

+8613126823610 yhe@ipb.pumc.edu.cn

Fan Wang

CONTACT

+8618534115213 wangfan3063@163.com

Data from ClinicalTrials.gov

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Changes of blood lactate will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in body temperature of Vital Signs.

Body temperature in Celsius degree

Time frame: Within 71 days after the first administration.

Changes from baseline in red blood cell count of Laboratory Examination.

Red blood cell count in whole blood is reported in the form of number.

Time frame: Within 71 days after the first administration.

Changes from baseline in white blood cell count of Laboratory Examination.

White blood cell count in whole blood is reported in the form of number.

Time frame: Within 71 days after the first administration.

Changes from baseline in neutrophil count of Laboratory Examination.

Neutrophil count in whole blood is reported in the form of number.

Time frame: Within 71 days after the first administration.

Changes from baseline in lymphocyte count of Laboratory Examination.

Lymphocyte count in whole blood is reported in the form of number.

Time frame: Within 71 days after the first administration.

Changes from baseline in platelet count of Laboratory Examination.

Platelet count in whole blood is reported in the form of number.

Time frame: Within 71 days after the first administration.

Changes from baseline in hemoglobin of Laboratory Examination.

Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in PT of Laboratory Examination.

Prothrombin time (PT) is a screening test for exogenous coagulation factors.

Time frame: Within 71 days after the first administration.

Changes from baseline in INR of Laboratory Examination.

International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.

Time frame: Within 71 days after the first administration.

Changes from baseline in APTT of Laboratory Examination.

Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.

Time frame: Within 71 days after the first administration.

Changes from baseline in total bilirubin of Laboratory Examination.

Changes of total bilirubin concentration (μmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in direct bilirubin of Laboratory Examination.

Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in ALT of Laboratory Examination.

Changes of ALT concentration (U/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in AST of Laboratory Examination.

Changes of AST concentration (U/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in total protein of Laboratory Examination.

Changes of total protein concentration (g/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in albumin of Laboratory Examination.

Changes of albumin concentration (g/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in urea of Laboratory Examination.

Changes of urea concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in creatinine of Laboratory Examination.

Changes of creatinine concentration (μmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in uric acid of Laboratory Examination.

Changes of uric acid concentration (μmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in glucose of Laboratory Examination

Changes of glucose concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in potassium of Laboratory Examination.

Changes of potassium concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in sodium of Laboratory Examination.

Changes of sodium concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in chlorine of Laboratory Examination.

Changes of chlorine concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in urine specific gravity of Laboratory Examination.

Changes of urine specific gravity will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in urine pH of Laboratory Examination.

Changes of urine pH value will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in urine glucose of Laboratory Examination.

Changes of urine glucose will be examined by qualitative test (positive or negative).

Time frame: Within 71 days after the first administration.

Changes from baseline in urine protein of Laboratory Examination.

Changes of urine protein will be examined by qualitative test (positive or negative).

Time frame: Within 71 days after the first administration.

Changes from baseline in urine ketone body of Laboratory Examination.

Changes of urine ketone body will be examined by qualitative test (positive or negative).

Time frame: Within 71 days after the first administration.

Changes from baseline in urine white blood cell of Laboratory Examination.

Changes of white blood cell in urine will be examined by qualitative test (positive or negative).

Time frame: Within 71 days after the first administration.

Changes from baseline in urine bilirubin of Laboratory Examination.

Changes of urine bilirubin will be examined by qualitative test (positive or negative).

Time frame: Within 71 days after the first administration.

Changes from baseline in urine occult blood of Laboratory Examination.

Changes of urine occult blood will be examined by qualitative test (positive or negative).

Time frame: Within 71 days after the first administration.

Changes from baseline in Electrocardiogram.

The cardiac rhythm is showed in electrocardiogram in the form of continuous curve.

Time frame: Within 71 days after the first administration.

Changes from baseline in CK of Laboratory Examination

Changes of CK concentration (U/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in CK-MB of Laboratory Examination

Changes of CK-MB concentration (ng/mL) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in LDH of Laboratory Examination

Changes of LDH concentration (U/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in ALP of Laboratory Examination

Changes of ALP concentration (U/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in Triglyceride of Laboratory Examination

Changes of Triglyceride concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in CHOL of Laboratory Examination

Changes of CHOL concentration (mmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in TP of Laboratory Examination

Changes of TP concentration (g/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in ALB of Laboratory Examination

Changes of ALB concentration (g/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Changes from baseline in UA of Laboratory Examination

Changes of UA concentration (μmol/L) in serum will be recorded.

Time frame: Within 71 days after the first administration.

Pharmacokinetics：Cmax

pharmacokinetic characteristics of LP-98 in infected patients：Cmax

Time frame: Within 71 days after the first administration.

Pharmacokinetics：AUC0-t

pharmacokinetic characteristics of LP-98 in infected patients：AUC0-t

Time frame: Within 71 days after the first administration.

Pharmacokinetics：AUC0-∞

pharmacokinetic characteristics of LP-98 in infected patients：AUC0-∞

Time frame: Within 71 days after the first administration.