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CompletedNCT05933824Updated May 15, 2026

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects

A Phase 1 interventional study of LP-98 injection in HIV (Human Immunodeficiency Virus), sponsored by Shanxi Kangbao Biological Product Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Shanxi Kangbao Biological Product Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

A randomized, placebo-controlled, single-administration, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of LP-98 injection in healthy subjects in a first-in-human clinical study

Read the detailed description

The study was divided into two parts, Part A and Part B. The Part A and Part B studies were carried out separately according to the protocol flow, with the Part A study carried out first.

  1. Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.
  2. Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.
02

Conditions studied

  • HIV (Human Immunodeficiency Virus)

Keywords

  • Healthy Subjects
  • safety and tolerability
  • pharmacokinetic (PK)
  • immunogenicity
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 36 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Shanxi Kangbao Biological Product Co., Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Subjects must meet all of the following inclusion criteria for study entry:

  1. Willing to participate in the study and sign ICF with clear date;
  2. Aged 18 to 55 years at the screening visit, male or female;
  3. Body weight ≥ 50 kg for males or body weight ≥ 45 kg for females, and body mass index (BMI) within the range of 19 to 28 kg/m2 (inclusive);
  4. Be in good health in the PI's judgment, with no clinical significance in previous medical history, laboratory tests, physical examinations, vital signs, and ECG findings;
  5. All subjects and his/her partners must agree to use effective non-drug contraception (except for subjects had permanent contraception, i.e., bilateral tubal ligation or vasectomy, etc.) from 2 weeks prior to screening to 3 months after finishing the study. Females must have a negative serum human chorionic gonadotropin (hCG) test for pregnancy confirmation at screening;
  6. Willing to comply with the visits, treatments, laboratory tests and other study process required by the protocol.

Exclusion criteria

Exclusion Criteria:

  1. Allergic to the IP or its excipients, or medicine of the same class , or having a history of severe allergies (including any food allergy or drug allergy);
  2. With history or family history of psychiatric, or history of chronic or serious disorders of the central nervous system, cardiovascular, hepatic, nephrological, pulmanory, digestive, metabolic, hematological or skeletal system etc., or definitive history of myelosuppression, orany other significant history of disease that may affect the safety or PK parameters in the PI's judgment;
  3. Having positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody;
  4. Having clinically significant abnormal results of vital signs or laboratory tests required by the protocol;
  5. Having clinically significant abnormality of 12-lead ECG, or having a QTcF interval (using Fridericia's correction) > 450 ms for males or > 470 ms for females;
  6. With serum creatine clearance rate (Ccr) \< 80 ml/min/1.73 m2 (based on Cockcroft-Gault formula);
  7. Known or suspected history of drug abuse (i.e., morphine, methamphetamine, ketamine, dimethylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine etc.), or having positive result for drug abuse;
  8. With history of heavy alcohol consumption within 1 year prior to screening (more than 21 units of alcohol per week, i.e., 360 ml of 5% beer, 45 ml of 40% hard liquor, 120 ml of 12% wine, or positive alcohol test;
  9. Smoking more than 5 cigarettes per day within 3 months prior to screening, or inability to comply with the prohibition of smoking during the study;
  10. Consuming amount > 6 servings of coffee, tea, cola, energy-drink, or other caffeine-containing product per day. One serving ≈ 120 mg of caffeine. Or consumed any caffeine-containing product within 24 hours prior to the dosing of the IP;
  11. Had received vaccination within 30 days prior to screening, or planning to receive vaccination during the study;
  12. Had received any prescription and non-prescription drugs, herbal remedies, or dietary supplements within 14 days prior to the dosing of the IP;
  13. Participated in any other clinical trial within 3 months prior to screening;
  14. Had received surgical operation within 3 months prior to screening, or planning to receive surgical operation during the study;
  15. Currently pregnant or lactating women；
  16. Had blood donation or blood loss over 200 mL within 3 months prior to screening, or planning to donate blood during the study；
  17. Cannot tolerate venipuncture blood collection and/or have a history of blood or needle sickness
  18. Other conditions considered to be ineligible for study entry in the PI's judgment
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    PartA:Dose level(5mg)

    Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

    Drug: LP-98 injection

  • Experimental
    PartA:Dose level(10mg)

    Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

    Drug: LP-98 injection

  • Experimental
    PartA:Dose level(20mg)

    Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

    Drug: LP-98 injection

  • Experimental
    PartA:Dose level(40mg)

    Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

    Drug: LP-98 injection

  • Experimental
    PartA:Dose level(80mg)

    Part A is set up with 5 cohorts(5mg, 10mg, 20mg, 40mg, 80mg), administration is by subcutaneous, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 5, to observe the safety, tolerability, PK and ADA of LP-98 injection by subcutaneous.

    Drug: LP-98 injection

  • Experimental
    PartB:Dose level(5mg)

    Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

    Drug: LP-98 injection

  • Experimental
    PartB:Dose level(10mg)

    Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

    Drug: LP-98 injection

  • Experimental
    PartB:Dose level(20mg)

    Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

    Drug: LP-98 injection

  • Experimental
    PartB:Dose level(40mg)

    Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

    Drug: LP-98 injection

  • Experimental
    PartB:Dose level(80mg)

    Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

    Drug: LP-98 injection

  • Experimental
    PartB:Dose level(160mg)

    Part B is set up with 6 cohorts (5mg,10mg,20mg,40mg,80mg, 160mg), administration is by intravenous drip, each subject entered only one cohort to receive the drug. 4 subjects were included in cohort 1, and 8 subjects were planned to be included in each cohort 2 to 6, to observe the safety, tolerability, PK and ADA of LP-98 injection by intravenous drip.

    Drug: LP-98 injection

Interventions

  • DrugLP-98 injection

    Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo

    Also known as: placebo-controlled

06

What researchers measure

Primary outcomes

  1. Changes from baseline in respiration rate of Vital Signs

    Respiration rate in times / minute

    Time frame: Within 36 days after the first administration.

  2. Changes from baseline in blood pressure of Vital Signs.

    Blood pressure in mmHg

    Time frame: Within 36 days after the first administration.

  3. Changes from baseline in body temperature of Vital Signs.

    Body temperature in Celsius degree

    Time frame: Within 36 days after the first administration.

  4. Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads

    Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

    Time frame: within 36 days after administration

  5. Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads

    Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

    Time frame: within 36 days after administration

  6. Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads

    Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.

    Time frame: within 36 days after administration

  7. Changes from baseline in Blood lactate of Laboratory Examination.

    Changes of blood lactate will be recorded.

    Time frame: within 36 days after administration

  8. Changes from baseline in Pregnancy test of Laboratory Examination.

    Pregnancy test will be tested in female subjects.

    Time frame: within 36 days after administration

  9. 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 36 days after administration

  10. 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 36 days after administration

  11. Changes from baseline in neutrophil count of Laboratory Examination.

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

    Time frame: within 36 days after administration

  12. Changes from baseline in lymphocyte count of Laboratory Examination.

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

    Time frame: within 36 days after administration

  13. Changes from baseline in platelet count of Laboratory Examination.

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

    Time frame: within 36 days after administration

  14. Changes from baseline in hemoglobin of Laboratory Examination.

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

    Time frame: within 36 days after administration

  15. Changes from baseline in PT of Laboratory Examination.

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

    Time frame: within 36 days after administration

  16. 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 36 days after administration

  17. Changes from baseline in APTT of Laboratory Examination.

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

    Time frame: within 36 days after administration

  18. Changes from baseline in direct bilirubin of Laboratory Examination.

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

    Time frame: within 36 days after administration

  19. Changes from baseline in ALT of Laboratory Examination.

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

    Time frame: within 36 days after administration

  20. Changes from baseline in AST of Laboratory Examination.

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

    Time frame: within 36 days after administration

  21. Changes from baseline in total protein of Laboratory Examination.

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

    Time frame: within 36 days after administration

  22. Changes from baseline in albumin of Laboratory Examination.

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

    Time frame: within 36 days after administration

  23. Changes from baseline in creatinine of Laboratory Examination.

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

    Time frame: within 36 days after administration

  24. Changes from baseline in glucose of Laboratory Examination

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

    Time frame: within 36 days after administration

  25. Changes from baseline in potassium of Laboratory Examination.

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

    Time frame: within 36 days after administration

  26. Changes from baseline in sodium of Laboratory Examination.

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

    Time frame: within 36 days after administration

  27. Changes from baseline in chlorine of Laboratory Examination.

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

    Time frame: within 36 days after administration

  28. Changes from baseline in urine specific gravity of Laboratory Examination.

    Changes of urine specific gravity will be recorded.

    Time frame: within 36 days after administration

  29. Changes from baseline in urine pH of Laboratory Examination.

    Changes of urine pH value will be recorded.

    Time frame: within 36 days after administration

  30. 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 36 days after administration

  31. 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 36 days after administration

  32. 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 36 days after administration

  33. 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 36 days after administration

  34. 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 36 days after administration

  35. Changes from baseline in CK of Laboratory Examination

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

    Time frame: within 36 days after administration

  36. Changes from baseline in CK-MB of Laboratory Examination

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

    Time frame: within 36 days after administration

  37. Changes from baseline in LDH of Laboratory Examination

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

    Time frame: within 36 days after administration

  38. Changes from baseline in ALP of Laboratory Examination

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

    Time frame: within 36 days after administration

  39. Changes from baseline in Triglyceride of Laboratory Examination

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

    Time frame: within 36 days after administration

  40. Changes from baseline in CHOL of Laboratory Examination

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

    Time frame: within 36 days after administration

Secondary outcomes

  1. 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.

    Time frame: within 36 days after administration

  2. Pharmacokinetics：Cmax

    pharmacokinetic characteristics of Lipovirtide in infected patients：Cmax

    Time frame: within 36 days after administration

  3. Pharmacokinetics：AUC0-t

    pharmacokinetic characteristics of Lipovirtide in infected patients：AUC0-t

    Time frame: within 36 days after administration

  4. Pharmacokinetics：AUC0-∞

    pharmacokinetic characteristics of Lipovirtide in infected patients：AUC0-∞

    Time frame: within 36 days after administration

Other outcomes

  1. Explore changes in biomarkers (CD4+, CD8+T cell counts) from baseline after administration

    Changes of CD4+T cell counts will be recorded.

    Time frame: within 36 days after administration

07

Study locations

1 site
  • Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
    Zhengzhou, Henan 450000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05933824
Lead sponsor
Shanxi Kangbao Biological Product Co., Ltd.
Collaborators
Institute of Pathogen Biology, Beijing, China
Responsible party
Sponsor
First posted
Jul 6, 2023
Start date
Jul 13, 2023
Primary completion
Apr 12, 2024
Completion
Apr 12, 2024
Last update
May 15, 2026

Study contacts

Shuang Li, Master
principal investigator · Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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