HIV (Human Immunodeficiency Virus)Phase 1NCT05933824
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects
A Phase 1 study testing LP-98 injection in people with HIV (Human Immunodeficiency Virus), run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV (Human Immunodeficiency Virus)
- What is being tested?
- LP-98 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2023to 12 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria for study entry:
- Willing to participate in the study and sign ICF with clear date;
- Aged 18 to 55 years at the screening visit, male or female;
- 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);
- 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;
- 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;
- Willing to comply with the visits, treatments, laboratory tests and other study process required by the protocol.
Who cannot join
- 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);
- 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;
- Having positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody;
- Having clinically significant abnormal results of vital signs or laboratory tests required by the protocol;
- 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;
- With serum creatine clearance rate (Ccr) < 80 ml/min/1.73 m2 (based on Cockcroft-Gault formula);
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- Known or suspected history of drug abuse (i.e., morphine, methamphetamine, ketamine, dimethylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine etc.), or having positive result for drug abuse;
- 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;
- 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;
- 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;
- Had received vaccination within 30 days prior to screening, or planning to receive vaccination during the study;
- Had received any prescription and non-prescription drugs, herbal remedies, or dietary supplements within 14 days prior to the dosing of the IP;
- Participated in any other clinical trial within 3 months prior to screening;
- Had received surgical operation within 3 months prior to screening, or planning to receive surgical operation during the study;
- Currently pregnant or lactating women；
- Had blood donation or blood loss over 200 mL within 3 months prior to screening, or planning to donate blood during the study；
- Cannot tolerate venipuncture blood collection and/or have a history of blood or needle sickness
- Other conditions considered to be ineligible for study entry in the PI's judgment
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
Zhengzhou, Henan, 450000
About this study
Official title: 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
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.
- 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.
- 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.
- Conditions
- HIV (Human Immunodeficiency Virus)
- Being tested
- LP-98 injection
- Keywords
- Healthy Subjects, safety and tolerability, pharmacokinetic (PK), immunogenicity
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-98 injectionDrug
Also called placebo-controlled
Part A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo
| Study group | Role | What they receive |
|---|---|---|
| PartA:Dose level(5mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartA:Dose level(10mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartA:Dose level(20mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartA:Dose level(40mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartA:Dose level(80mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartB:Dose level(5mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartB:Dose level(10mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartB:Dose level(20mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartB:Dose level(40mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartB:Dose level(80mg) | Experimental | 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. Receives: Drug: LP-98 injection |
| PartB:Dose level(160mg) | Experimental | 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. Receives: Drug: LP-98 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in respiration rate of Vital Signs
Respiration rate in times / minute
Measured: Within 36 days after the first administration.
Changes from baseline in blood pressure of Vital Signs.
Blood pressure in mmHg
Measured: Within 36 days after the first administration.
Changes from baseline in body temperature of Vital Signs.
Body temperature in Celsius degree
Measured: Within 36 days after the first administration.
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.
Measured: within 36 days after administration
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.
Measured: within 36 days after administration
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.
Measured: within 36 days after administration
Changes from baseline in Blood lactate of Laboratory Examination.
Changes of blood lactate will be recorded.
Measured: within 36 days after administration
Changes from baseline in Pregnancy test of Laboratory Examination.
Pregnancy test will be tested in female subjects.
Measured: within 36 days after 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.
Measured: within 36 days after 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.
Measured: within 36 days after administration
Changes from baseline in neutrophil count of Laboratory Examination.
Neutrophil count in whole blood is reported in the form of number.
Measured: within 36 days after administration
Changes from baseline in lymphocyte count of Laboratory Examination.
Lymphocyte count in whole blood is reported in the form of number.
Measured: within 36 days after administration
Changes from baseline in platelet count of Laboratory Examination.
Platelet count in whole blood is reported in the form of number.
Measured: within 36 days after administration
Changes from baseline in hemoglobin of Laboratory Examination.
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Measured: within 36 days after administration
Changes from baseline in PT of Laboratory Examination.
Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Measured: within 36 days after 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.
Measured: within 36 days after administration
Changes from baseline in APTT of Laboratory Examination.
Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in direct bilirubin of Laboratory Examination.
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in ALT of Laboratory Examination.
Changes of ALT concentration (U/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in AST of Laboratory Examination.
Changes of AST concentration (U/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in total protein of Laboratory Examination.
Changes of total protein concentration (g/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in albumin of Laboratory Examination.
Changes of albumin concentration (g/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in creatinine of Laboratory Examination.
Changes of creatinine concentration (μmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in glucose of Laboratory Examination
Changes of glucose concentration (mmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in potassium of Laboratory Examination.
Changes of potassium concentration (mmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in sodium of Laboratory Examination.
Changes of sodium concentration (mmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in chlorine of Laboratory Examination.
Changes of chlorine concentration (mmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in urine specific gravity of Laboratory Examination.
Changes of urine specific gravity will be recorded.
Measured: within 36 days after administration
Changes from baseline in urine pH of Laboratory Examination.
Changes of urine pH value will be recorded.
Measured: within 36 days after administration
Changes from baseline in urine glucose of Laboratory Examination.
Changes of urine glucose will be examined by qualitative test (positive or negative).
Measured: within 36 days after administration
Changes from baseline in urine protein of Laboratory Examination.
Changes of urine protein will be examined by qualitative test (positive or negative).
Measured: within 36 days after 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).
Measured: within 36 days after 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).
Measured: within 36 days after 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).
Measured: within 36 days after administration
Changes from baseline in CK of Laboratory Examination
Changes of CK concentration (U/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in CK-MB of Laboratory Examination
Changes of CK-MB concentration (ng/mL) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in LDH of Laboratory Examination
Changes of LDH concentration (U/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in ALP of Laboratory Examination
Changes of ALP concentration (U/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in Triglyceride of Laboratory Examination
Changes of Triglyceride concentration (mmol/L) in serum will be recorded.
Measured: within 36 days after administration
Changes from baseline in CHOL of Laboratory Examination
Changes of CHOL concentration (mmol/L) in serum will be recorded.
Measured: within 36 days after administration
Secondary outcomes (4)
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.
Measured: within 36 days after administration
Pharmacokinetics：Cmax
pharmacokinetic characteristics of Lipovirtide in infected patients：Cmax
Measured: within 36 days after administration
Pharmacokinetics：AUC0-t
pharmacokinetic characteristics of Lipovirtide in infected patients：AUC0-t
Measured: within 36 days after administration
Pharmacokinetics：AUC0-∞
pharmacokinetic characteristics of Lipovirtide in infected patients：AUC0-∞
Measured: within 36 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start13 Jul 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanxi Kangbao Biological Product Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Pathogen Biology, Beijing, China
- Responsible party
- Sponsor
- Investigators
- Shuang Li, Master, Principal investigator, Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933824
- Sponsor's protocol ID
- KB_LP-98_101
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05933824
- Acronym / sponsor ID
- KB_LP-98_101
- Conditions
- HIV (Human Immunodeficiency Virus)
- Keywords
- Healthy Subjects, safety and tolerability, pharmacokinetic (PK), immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shanxi Kangbao Biological Product Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Institute of Pathogen Biology, Beijing, China
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| PartA:Dose level(5mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartA:Dose level(10mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartA:Dose level(20mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartA:Dose level(40mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartA:Dose level(80mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartB:Dose level(5mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartB:Dose level(10mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartB:Dose level(20mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartB:Dose level(40mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartB:Dose level(80mg) | Experimental | Drug: LP-98 injectionPart 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. |
| PartB:Dose level(160mg) | Experimental | Drug: LP-98 injectionPart 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Willing to participate in the study and sign ICF with clear date;
- Aged 18 to 55 years at the screening visit, male or female;
- 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);
- 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;
- 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;
Key exclusion criteria (18 listed)
- 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);
- 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;
- Having positive result for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody;
- Having clinically significant abnormal results of vital signs or laboratory tests required by the protocol;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP-98 injectionAlso: placebo-controlledPart A is administration is by subcutaneous LP98/placebo,Part B is administration is by intravenous drip LP98/placebo | Drug | PartA:Dose level(10mg), PartA:Dose level(20mg), PartA:Dose level(40mg), PartA:Dose level(5mg), PartA:Dose level(80mg), PartB:Dose level(10mg), PartB:Dose level(160mg), PartB:Dose level(20mg), PartB:Dose level(40mg), PartB:Dose level(5mg), PartB:Dose level(80mg) |
Primary outcome
Changes from baseline in respiration rate of Vital Signs
Time frame: Within 36 days after the first administration.
Respiration rate in times / minute
Changes from baseline in blood pressure of Vital Signs.
Time frame: Within 36 days after the first administration.
Blood pressure in mmHg
Changes from baseline in body temperature of Vital Signs.
Time frame: Within 36 days after the first administration.
Body temperature in Celsius degree
Changes from baseline in ECG PR intervalThe cardiac rhythm is showed in 12 Leads
Time frame: within 36 days after administration
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Changes from baseline in ECG QRS intervalThe cardiac rhythm is showed in 12 Leads
Time frame: within 36 days after administration
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Changes from baseline in ECG QT intervalThe cardiac rhythm is showed in 12 Leads
Time frame: within 36 days after administration
Ambulatory Electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded.
Changes from baseline in Blood lactate of Laboratory Examination.
Time frame: within 36 days after administration
Changes of blood lactate will be recorded.
Changes from baseline in Pregnancy test of Laboratory Examination.
Time frame: within 36 days after administration
Pregnancy test will be tested in female subjects.
Changes from baseline in red blood cell count of Laboratory Examination.
Time frame: within 36 days after 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.
Time frame: within 36 days after administration
White blood cell count in whole blood is reported in the form of number.
Changes from baseline in neutrophil count of Laboratory Examination.
Time frame: within 36 days after administration
Neutrophil count in whole blood is reported in the form of number.
Changes from baseline in lymphocyte count of Laboratory Examination.
Time frame: within 36 days after administration
Lymphocyte count in whole blood is reported in the form of number.
Changes from baseline in platelet count of Laboratory Examination.
Time frame: within 36 days after administration
Platelet count in whole blood is reported in the form of number.
Changes from baseline in hemoglobin of Laboratory Examination.
Time frame: within 36 days after administration
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Changes from baseline in PT of Laboratory Examination.
Time frame: within 36 days after administration
Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Changes from baseline in INR of Laboratory Examination.
Time frame: within 36 days after 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.
Time frame: within 36 days after administration
Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in direct bilirubin of Laboratory Examination.
Time frame: within 36 days after administration
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in ALT of Laboratory Examination.
Time frame: within 36 days after administration
Changes of ALT concentration (U/L) in serum will be recorded.
Changes from baseline in AST of Laboratory Examination.
Time frame: within 36 days after administration
Changes of AST concentration (U/L) in serum will be recorded.
Changes from baseline in total protein of Laboratory Examination.
Time frame: within 36 days after administration
Changes of total protein concentration (g/L) in serum will be recorded.
Changes from baseline in albumin of Laboratory Examination.
Time frame: within 36 days after administration
Changes of albumin concentration (g/L) in serum will be recorded.
Changes from baseline in creatinine of Laboratory Examination.
Time frame: within 36 days after administration
Changes of creatinine concentration (μmol/L) in serum will be recorded.
Changes from baseline in glucose of Laboratory Examination
Time frame: within 36 days after administration
Changes of glucose concentration (mmol/L) in serum will be recorded.
Changes from baseline in potassium of Laboratory Examination.
Time frame: within 36 days after administration
Changes of potassium concentration (mmol/L) in serum will be recorded.
Changes from baseline in sodium of Laboratory Examination.
Time frame: within 36 days after administration
Changes of sodium concentration (mmol/L) in serum will be recorded.
Changes from baseline in chlorine of Laboratory Examination.
Time frame: within 36 days after administration
Changes of chlorine concentration (mmol/L) in serum will be recorded.
Changes from baseline in urine specific gravity of Laboratory Examination.
Time frame: within 36 days after administration
Changes of urine specific gravity will be recorded.
Changes from baseline in urine pH of Laboratory Examination.
Time frame: within 36 days after administration
Changes of urine pH value will be recorded.
Changes from baseline in urine glucose of Laboratory Examination.
Time frame: within 36 days after administration
Changes of urine glucose will be examined by qualitative test (positive or negative).
Changes from baseline in urine protein of Laboratory Examination.
Time frame: within 36 days after administration
Changes of urine protein will be examined by qualitative test (positive or negative).
Changes from baseline in urine ketone body of Laboratory Examination.
Time frame: within 36 days after 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.
Time frame: within 36 days after administration
Changes of white blood cell in urine will be examined by qualitative test (positive or negative).
Changes from baseline in urine occult blood of Laboratory Examination.
Time frame: within 36 days after administration
Changes of urine occult blood will be examined by qualitative test (positive or negative).
Changes from baseline in CK of Laboratory Examination
Time frame: within 36 days after administration
Changes of CK concentration (U/L) in serum will be recorded.
Changes from baseline in CK-MB of Laboratory Examination
Time frame: within 36 days after administration
Changes of CK-MB concentration (ng/mL) in serum will be recorded.
Changes from baseline in LDH of Laboratory Examination
Time frame: within 36 days after administration
Changes of LDH concentration (U/L) in serum will be recorded.
Changes from baseline in ALP of Laboratory Examination
Time frame: within 36 days after administration
Changes of ALP concentration (U/L) in serum will be recorded.
Changes from baseline in Triglyceride of Laboratory Examination
Time frame: within 36 days after administration
Changes of Triglyceride concentration (mmol/L) in serum will be recorded.
Changes from baseline in CHOL of Laboratory Examination
Time frame: within 36 days after administration
Changes of CHOL concentration (mmol/L) in serum will be recorded.
4 secondary outcomes
Changes from baseline in Immunogenic blood collection of Laboratory Examination.
Time frame: within 36 days after administration
Pharmacokinetics：Cmax
Time frame: within 36 days after administration
Pharmacokinetics：AUC0-t
Time frame: within 36 days after administration
Pharmacokinetics：AUC0-∞
Time frame: within 36 days after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuang Li, Master principal investigator
Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LP-98 injection in people with HIV (Human Immunodeficiency Virus), run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in respiration rate of Vital Signs (time frame: Within 36 days after the first administration.). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.