HIVPhase 1/2NCT07433387
Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals
A Phase 1/2 study testing LP-98 20 mg, LP-98 40 mg and LP-98 80 mg in people with HIV, run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.
Trial summary
An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 for Injection in Antiretroviral Therapy-Naive HIV-Infected Individuals Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- LP-98 20 mg, LP-98 40 mg and LP-98 80 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to 25 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments.
- At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female.
- At the time of screening, male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg.
- Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL.
- For Female Subjects: Only non-reproductive females will be included, which includes those who have undergone surgical sterilization (documented hysterectomy or bilateral oophorectomy) at least 6 weeks prior to the screening visit, or those who have been postmenopausal for at least 12 months (confirmed by a follicle-stimulating hormone (FSH) level ≥40 IU/L).
- For Male Subjects with Fertile Female Partners: The subject must agree to use a non-pharmacological contraception method for 14 days prior to dosing, during the study, and for 3 months following the administration of the study drug. Male subjects must not donate sperm during this period.
- The subject must be willing to adhere to the study protocol, including visits, study treatment, laboratory tests, and other study-related procedures and requirements.
Who cannot join
- Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies).
- Has previously received antiviral therapy (ART) or has been vaccinated against HIV.
- A history of severe disease or the presence of other severe chronic conditions.
- A history of mental health disorders or a family history of psychiatric diseases.
- Any of the Following Conditions:
- 1）Persistent unexplained fever above 38°C within 1 month prior to screening or during the screening phase.
Show all 20Show fewer
- 2）Persistent diarrhea (more than 3 bowel movements per day) within 1 month prior to screening or during the screening phase.
- 3）Severe infections, opportunistic infections, or sepsis within 6 months prior to screening or during the screening phase.
- 6、Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
- 7、Abnormal 12-lead electrocardiogram (ECG) findings with clinical significance at screening, such as a male QTcF interval (Fridericia correction formula) > 450 ms, or female QTcF > 470 ms.
- 8、Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN), or total bilirubin > 1.5 times ULN at screening.
- 9、Serum creatinine clearance (Ccr) < 60 mL/min at screening (calculated using the Cockcroft-Gault formula).
- 10、Known or suspected history of drug abuse (including morphine, methamphetamine, ketamine, dimethylthioamphetamine, tetrahydrocannabinolic acid, cocaine), or a positive baseline drug screening test.
- 11、A history of alcohol abuse within the past year (defined as consuming more than 14 standard units of alcohol per week, where 1 standard unit is 14 g of alcohol, equivalent to 360 mL of 5% beer, 45 mL of 40% liquor, or 120 mL of 12% wine), or inability to comply with the study's alcohol prohibition during the study.
- 12、Smoking more than 5 cigarettes per day within the last 3 months prior to screening, or inability to comply with the study's smoking prohibition during the study.
- 13、Receiving any vaccine within 3 months prior to screening, or planning to receive any vaccine during the study.
- 14、Received any investigational drug treatment or participated in any drug/device trial (excluding in vitro diagnostic devices) within 3 months prior to dosing.
- 15、Major surgery within 30 days prior to dosing, or planned major surgery during the study.
- 16、Blood donation or loss of ≥ 400 mL within 3 months prior to screening, or receiving a blood transfusion during this period.
- 17、Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, 300000
Ping Ma, Doctor, +8615922124490, mapingtianjin@163.com
About this study
Official title: An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 forInjection in Antiretroviral Therapy-Naive HIV-Infected Individuals
An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 for Injection in Antiretroviral Therapy-Naive HIV-Infected Individuals
Read the detailed description
The study utilizes a sequential cohort design, with three dosage cohorts (20 mg, 40 mg, 80 mg). The cohorts will be enrolled sequentially from low to high doses, with the next dose group initiating subject screening and enrollment after the last subject in the previous cohort has been enrolled.
The study plans to enroll a total of 30 subjects, with 10 subjects in each cohort. Enrolled subjects will receive LP-98 treatment at doses of 20 mg, 40 mg, or 80 mg according to their assigned cohort. The drug will be administered via subcutaneous injection, with an interval of 14 days between doses, for a total of 4 doses.
The study includes a screening phase (D-28 to D-1), a treatment phase (D1 to D57), and a follow-up phase (D58 to D71). The total duration of participation for each subject is approximately 99 days.
- Conditions
- HIV
- Being tested
- LP-98 20 mg, LP-98 40 mg, LP-98 80 mg
- Keywords
- LP-98
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-98 20 mgDrug
The study plans to enroll a total of 30 subjects, with 10 subjects in each cohort. Enrolled subjects will receive LP-98 treatment at doses of 20 mg, 40 mg, or 80 mg according to their assigned cohort. The drug will be administered via subcutaneous injection, with an interval of 14 days between doses, for a total of 4 doses.
LP-98 40 mgDrug
LP-98 40 mg
LP-98 80 mgDrug
LP-98 80 mg
| Study group | Role | What they receive |
|---|---|---|
| LP-98 20 mg dose group | Experimental | A total of 10 subjects are planned to be enrolled in this cohort, and each enrolled subject will receive a 20 mg dose of LP-98 per administration. The drug will be administered via subcutaneous injection at an interval of 14 days, for a total of 4 administrations. Receives: Drug: LP-98 20 mg |
| LP-98 40 mg dose group | Experimental | A total of 10 subjects are planned to be enrolled in this cohort, and each enrolled subject will receive a 40 mg dose of LP-98 per administration. The drug will be administered via subcutaneous injection at an interval of 14 days, for a total of 4 administrations. Receives: Drug: LP-98 40 mg |
| LP-98 80 mg dose group | Experimental | A total of 10 subjects are planned to be enrolled in this cohort, and each enrolled subject will receive a 80 mg dose of LP-98 per administration. The drug will be administered via subcutaneous injection at an interval of 14 days, for a total of 4 administrations. Receives: Drug: LP-98 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma HIV RNA levels (log10 copies/mL) and changes from baseline
Changes of HIV viral load detection will be recorded.
Measured: Within 71 days after the first administration.
Proportion of subjects with plasma HIV RNA < 50 copies/mL
Changes of HIV viral load detection will be recorded.
Measured: Within 71 days after the first administration.
Proportion of subjects with plasma HIV RNA < 200 copies/mL
Changes of HIV viral load detection will be recorded.
Measured: Within 71 days after the first administration.
Absolute CD4+ T lymphocyte count and change from baseline
Changes of CD4+T counts will be recorded.
Measured: Within 71 days after the first administration.
CD4+/CD8+ T lymphocyte ratio and change from baseline
Changes of CD4+/CD8+ T counts will be recorded.
Measured: Within 71 days after the first administration.
Secondary outcomes (47)
Changes from baseline in respiration rate of Vital Signs.
Respiration rate in times / minute
Measured: Within 71 days after the first administration.
Changes from baseline in blood pressure of Vital Signs.
Blood pressure in mmHg
Measured: Within 71 days after the first administration.
Changes from baseline in Blood lactate of Laboratory Examination.
Changes of blood lactate will be recorded.
Measured: Within 71 days after the first administration.
Changes from baseline in body temperature of Vital Signs.
Body temperature in Celsius degree
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 71 days after the first administration.
Changes from baseline in urine pH of Laboratory Examination.
Changes of urine pH value will be recorded.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 71 days after the first administration.
Pharmacokinetics：Cmax
pharmacokinetic characteristics of LP-98 in infected patients：Cmax
Measured: Within 71 days after the first administration.
Pharmacokinetics：AUC0-t
pharmacokinetic characteristics of LP-98 in infected patients：AUC0-t
Measured: Within 71 days after the first administration.
Pharmacokinetics：AUC0-∞
pharmacokinetic characteristics of LP-98 in infected patients：AUC0-∞
Measured: Within 71 days after the first administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start29 Jan 2026
- Primary completion10 Jul 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- Ping Ma, Doctor, Principal investigator, Tianjin Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433387
- Sponsor's protocol ID
- KB_LP-98_103
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 forInjection in Antiretroviral Therapy-Naive HIV-Infected Individuals
- ClinicalTrials.gov ID
- NCT07433387
- Acronym / sponsor ID
- KB_LP-98_103
- Conditions
- HIV
- Keywords
- LP-98
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanxi Kangbao Biological Product Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Institute of Pathogen Biology, Beijing, China
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
An Exploratory Multicenter, Open-label, Sequential Cohort Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetic Characteristics of LP-98 for Injection in Antiretroviral Therapy-Naive HIV-Infected Individuals
Detailed description
The study utilizes a sequential cohort design, with three dosage cohorts (20 mg, 40 mg, 80 mg). The cohorts will be enrolled sequentially from low to high doses, with the next dose group initiating subject screening and enrollment after the last subject in the previous cohort has been enrolled.
The study plans to enroll a total of 30 subjects, with 10 subjects in each cohort. Enrolled subjects will receive LP-98 treatment at doses of 20 mg, 40 mg, or 80 mg according to their assigned cohort. The drug will be administered via subcutaneous injection, with an interval of 14 days between doses, for a total of 4 doses.
The study includes a screening phase (D-28 to D-1), a treatment phase (D1 to D57), and a follow-up phase (D58 to D71). The total duration of participation for each subject is approximately 99 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LP-98 20 mg dose group | Experimental | Drug: LP-98 20 mgA total of 10 subjects are planned to be enrolled in this cohort, and each enrolled subject will receive a 20 mg dose of LP-98 per administration. The drug will be administered via subcutaneous injection at an interval of 14 days, for a total of 4 administrations. |
| LP-98 40 mg dose group | Experimental | Drug: LP-98 40 mgA total of 10 subjects are planned to be enrolled in this cohort, and each enrolled subject will receive a 40 mg dose of LP-98 per administration. The drug will be administered via subcutaneous injection at an interval of 14 days, for a total of 4 administrations. |
| LP-98 80 mg dose group | Experimental | Drug: LP-98 80 mgA total of 10 subjects are planned to be enrolled in this cohort, and each enrolled subject will receive a 80 mg dose of LP-98 per administration. The drug will be administered via subcutaneous injection at an interval of 14 days, for a total of 4 administrations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject must voluntarily agree to participate in the study and provide informed consent before undergoing any study-related assessments.
- At the time of screening, the subject must be between 18 and 65 years of age (inclusive), either male or female.
- At the time of screening, male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg.
- Plasma HIV RNA levels must be ≥1000 copies/mL, and CD4+ T lymphocyte count must be ≥200 cells/μL.
- For Female Subjects: Only non-reproductive females will be included, which includes those who have undergone surgical sterilization (documented hysterectomy or bilateral oophorectomy) at least 6 weeks prior to the screening visit, or those who have been postmenopausal for at least 12 months (confirmed by a follicle-stimulating hormone (FSH) level ≥40 IU/L).
Key exclusion criteria (20 listed)
- Known allergy to the study drug or its excipients, or a history of severe allergic reactions (including any food allergies or drug allergies).
- Has previously received antiviral therapy (ART) or has been vaccinated against HIV.
- A history of severe disease or the presence of other severe chronic conditions.
- A history of mental health disorders or a family history of psychiatric diseases.
- Any of the Following Conditions:
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 20 mgThe study plans to enroll a total of 30 subjects, with 10 subjects in each cohort. Enrolled subjects will receive LP-98 treatment at doses of 20 mg, 40 mg, or 80 mg according to their assigned cohort. The drug will be administered via subcutaneous injection, with an interval of 14 days between doses, for a total of 4 doses. | Drug | LP-98 20 mg dose group |
| LP-98 40 mgLP-98 40 mg | Drug | LP-98 40 mg dose group |
| LP-98 80 mgLP-98 80 mg | Drug | LP-98 80 mg dose group |
Primary outcome
Plasma HIV RNA levels (log10 copies/mL) and changes from baseline
Time frame: Within 71 days after the first administration.
Changes of HIV viral load detection will be recorded.
Proportion of subjects with plasma HIV RNA < 50 copies/mL
Time frame: Within 71 days after the first administration.
Changes of HIV viral load detection will be recorded.
Proportion of subjects with plasma HIV RNA < 200 copies/mL
Time frame: Within 71 days after the first administration.
Changes of HIV viral load detection will be recorded.
Absolute CD4+ T lymphocyte count and change from baseline
Time frame: Within 71 days after the first administration.
Changes of CD4+T counts will be recorded.
CD4+/CD8+ T lymphocyte ratio and change from baseline
Time frame: Within 71 days after the first administration.
Changes of CD4+/CD8+ T counts will be recorded.
47 secondary outcomes
Changes from baseline in respiration rate of Vital Signs.
Time frame: Within 71 days after the first administration.
Changes from baseline in blood pressure of Vital Signs.
Time frame: Within 71 days after the first administration.
Changes from baseline in Blood lactate of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in body temperature of Vital Signs.
Time frame: Within 71 days after the first administration.
Changes from baseline in red blood cell count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in white blood cell count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in neutrophil count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in lymphocyte count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in platelet count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in hemoglobin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in PT of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in INR of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in APTT of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in total bilirubin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in direct bilirubin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in ALT of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in AST of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in total protein of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in albumin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urea of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in creatinine of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in uric acid of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in glucose of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes from baseline in potassium of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in sodium of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in chlorine of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine specific gravity of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine pH of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine glucose of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine protein of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine ketone body of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine white blood cell of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine bilirubin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in urine occult blood of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in Electrocardiogram.
Time frame: Within 71 days after the first administration.
Changes from baseline in CK of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes from baseline in CK-MB of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes from baseline in LDH of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes from baseline in ALP of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes from baseline in Triglyceride of Laboratory Examination
Time frame: Within 71 days after the first administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Ping Ma, Doctor principal investigator
Tianjin Second 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 1/2 study testing LP-98 20 mg, LP-98 40 mg and LP-98 80 mg in people with HIV, 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 20 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: looking for participants now, as of the sponsor's last update on 11 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxian He, Doctor (+8613126823610, yhe@ipb.pumc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma HIV RNA levels (log10 copies/mL) and changes from baseline (time frame: Within 71 days after the first administration.). The study lists 5 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 11 May 2026.