Hiv
Conditions
Keywords
LP-98, Double-Blind, Treatment-Naive HIV-Infected Individuals
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).
Interventions
DRUGSubjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
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.
Sponsors
Shanxi Kangbao Biological Product Co., Ltd.
Institute of Pathogen Biology, Beijing, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in respiration rate of Vital Signs. | Within 71 days after the first administration. | Respiration rate in times / minute |
| Changes from baseline in blood pressure of Vital Signs. | Within 71 days after the first administration. | Blood pressure in mmHg |
| Changes from baseline in Blood lactate of Laboratory Examination. | Within 71 days after the first administration. | Changes of blood lactate will be recorded. |
| Changes from baseline in body temperature of Vital Signs. | Within 71 days after the first administration. | Body temperature in Celsius degree |
| Changes from baseline in red blood cell count of Laboratory Examination. | Within 71 days after the first administration. | Red blood cell count in whole blood is reported in the form of number. |
| Changes from baseline in white blood cell count of Laboratory Examination. | Within 71 days after the first administration. | White blood cell count in whole blood is reported in the form of number. |
| Changes from baseline in neutrophil count of Laboratory Examination. | Within 71 days after the first administration. | Neutrophil count in whole blood is reported in the form of number. |
| Changes from baseline in lymphocyte count of Laboratory Examination. | Within 71 days after the first administration. | Lymphocyte count in whole blood is reported in the form of number. |
| Changes from baseline in platelet count of Laboratory Examination. | Within 71 days after the first administration. | Platelet count in whole blood is reported in the form of number. |
| Changes from baseline in hemoglobin of Laboratory Examination. | Within 71 days after the first administration. | Changes of hemoglobin concentration（g/dL）in whole blood will be recorded. |
| Changes from baseline in PT of Laboratory Examination. | Within 71 days after the first administration. | Prothrombin time (PT) is a screening test for exogenous coagulation factors. |
| Changes from baseline in INR of Laboratory Examination. | Within 71 days after the first administration. | International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent. |
| Changes from baseline in APTT of Laboratory Examination. | Within 71 days after the first administration. | Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors. |
| Changes from baseline in total bilirubin of Laboratory Examination. | Within 71 days after the first administration. | Changes of total bilirubin concentration (μmol/L) in serum will be recorded. |
| Changes from baseline in direct bilirubin of Laboratory Examination. | Within 71 days after the first administration. | Changes of direct bilirubin concentration (μmol/L) in serum will be recorded. |
| Changes from baseline in ALT of Laboratory Examination. | Within 71 days after the first administration. | Changes of ALT concentration (U/L) in serum will be recorded. |
| Changes from baseline in AST of Laboratory Examination. | Within 71 days after the first administration. | Changes of AST concentration (U/L) in serum will be recorded. |
| Changes from baseline in total protein of Laboratory Examination. | Within 71 days after the first administration. | Changes of total protein concentration (g/L) in serum will be recorded. |
| Changes from baseline in albumin of Laboratory Examination. | Within 71 days after the first administration. | Changes of albumin concentration (g/L) in serum will be recorded. |
| Changes from baseline in urea of Laboratory Examination. | Within 71 days after the first administration. | Changes of urea concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in creatinine of Laboratory Examination. | Within 71 days after the first administration. | Changes of creatinine concentration (μmol/L) in serum will be recorded. |
| Changes from baseline in uric acid of Laboratory Examination. | Within 71 days after the first administration. | Changes of uric acid concentration (μmol/L) in serum will be recorded. |
| Changes from baseline in glucose of Laboratory Examination | Within 71 days after the first administration. | Changes of glucose concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in potassium of Laboratory Examination. | Within 71 days after the first administration. | Changes of potassium concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in sodium of Laboratory Examination. | Within 71 days after the first administration. | Changes of sodium concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in chlorine of Laboratory Examination. | Within 71 days after the first administration. | Changes of chlorine concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in urine specific gravity of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine specific gravity will be recorded. |
| Changes from baseline in urine pH of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine pH value will be recorded. |
| Changes from baseline in urine glucose of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine glucose will be examined by qualitative test (positive or negative). |
| Changes from baseline in urine protein of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine protein will be examined by qualitative test (positive or negative). |
| Changes from baseline in urine ketone body of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine ketone body will be examined by qualitative test (positive or negative). |
| Changes from baseline in urine white blood cell of Laboratory Examination. | Within 71 days after the first administration. | Changes of white blood cell in urine will be examined by qualitative test (positive or negative). |
| Changes from baseline in urine bilirubin of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine bilirubin will be examined by qualitative test (positive or negative). |
| Changes from baseline in urine occult blood of Laboratory Examination. | Within 71 days after the first administration. | Changes of urine occult blood will be examined by qualitative test (positive or negative). |
| Changes from baseline in Electrocardiogram. | Within 71 days after the first administration. | The cardiac rhythm is showed in electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded，To evaluate the incidence of abnormal electrocardiogram. |
| Changes from baseline in CK of Laboratory Examination | Within 71 days after the first administration. | Changes of CK concentration (U/L) in serum will be recorded. |
| Changes from baseline in CK-MB of Laboratory Examination | Within 71 days after the first administration. | Changes of CK-MB concentration (ng/mL) in serum will be recorded. |
| Changes from baseline in LDH of Laboratory Examination | Within 71 days after the first administration. | Changes of LDH concentration (U/L) in serum will be recorded. |
| Changes from baseline in ALP of Laboratory Examination | Within 71 days after the first administration. | Changes of ALP concentration (U/L) in serum will be recorded. |
| Changes from baseline in Triglyceride of Laboratory Examination | Within 71 days after the first administration. | Changes of Triglyceride concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in CHOL of Laboratory Examination | Within 71 days after the first administration. | Changes of CHOL concentration (mmol/L) in serum will be recorded. |
| Changes from baseline in TP of Laboratory Examination | Within 71 days after the first administration. | Changes of TP concentration (g/L) in serum will be recorded. |
| Changes from baseline in ALB of Laboratory Examination | Within 71 days after the first administration. | Changes of ALB concentration (g/L) in serum will be recorded. |
| Changes from baseline in UA of Laboratory Examination | Within 71 days after the first administration. | Changes of UA concentration (μmol/L) in serum will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Immunogenic blood collection of Laboratory Examination. | Within 71 days after the first administration. | Changes of immunogenic blood collection will be recorded.The historical changes of test results (including positive rate and titer) of various indicators were counted. |
| Changes from baseline in HIV viral load detection of Laboratory Examination. | Within 71 days after the first administration. | Changes of HIV viral load detection will be recorded. |
| Changes from baseline in CD4+T cell counts of Laboratory Examination. | Within 71 days after the first administration. | Changes of CD4+T cell counts will be recorded. |
Countries
China
Contacts
STUDY_DIRECTORQingxia Zhao, Doctor
Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
Outcome results
None listed