Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients
NCT Number: NCT06560489
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Hiv
Interventions: DRUG: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
Sponsor: Shanxi Kangbao Biological Product Co., Ltd.
Collaborators: National Institute of Pathogen Biology， Chinese Academy of Medical Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-05-20

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

Primary Outcome Measures: Changes from baseline in respiration rate of Vital Signs., Respiration rate in times / minute, Within 71 days after the first administration.|Changes from baseline in blood pressure of Vital Signs., Blood pressure in mmHg, Within 71 days after the first administration.|Changes from baseline in Blood lactate of Laboratory Examination., Changes of blood lactate will be recorded., Within 71 days after the first administration.|Changes from baseline in body temperature of Vital Signs., Body temperature in Celsius degree, 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., 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., Within 71 days after the first administration.|Changes from baseline in urine pH of Laboratory Examination., Changes of urine pH value will be recorded., 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)., 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)., 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)., 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)., 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)., 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)., 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. Changes of this continuous curve will be recorded，To evaluate the incidence of abnormal electrocardiogram., 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., 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., 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., 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., 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., 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., 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., 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., 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., Within 71 days after the first administration.
Secondary Outcome Measures: Changes from baseline in Immunogenic blood collection of Laboratory Examination., Changes of immunogenic blood collection will be recorded.The historical changes of test results (including positive rate and titer) of various indicators were counted., Within 71 days after the first administration.|Changes from baseline in HIV viral load detection of Laboratory Examination., Changes of HIV viral load detection will be recorded., Within 71 days after the first administration.|Changes from baseline in CD4+T cell counts of Laboratory Examination., Changes of CD4+T cell counts will be recorded., Within 71 days after the first administration.