Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients

Shanxi Kangbao Biological Product Co., Ltd.40 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hiv

Interventions

Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)

Zhengzhou, Henan, China