HivPhase 1/2NCT06560489

Pharmacokinetics and Efficacy of Multiple Dosing of LP-98 for Injection in HIV-infected Patients

A Phase 1/2 study testing Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98. in people with Hiv, run by Shanxi Kangbao Biological Product Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Randomized, Double-Blind, Parallel-Group, Exploratory Clinical Study to Evaluate the Safety, Pharmacodynamic Effects, and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98 in Treatment-Naive HIV-Infected Individuals Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hiv
What is being tested?: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 2 Sep 2024to 22 Aug 2025
Phase: Phase 1/2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily participate in the study and obtain informed consent prior to any study-related evaluation;
Aged 18-65 years at the time of the screening visit (including the cut-off), male or female;
At the time of screening visit, the weight of male subjects is not less than 50 kg and that of female subjects is not less than 45 kg;
Plasma HIV RNA level ≥1000 copies /mL, CD4+T lymphocyte count ≥200 /μL;
For female subjects: Only subjects with no reproductive potential were included, including surgical sterilization at least 6 weeks prior to the screening visit (documented hysterectomy or bilateral oopectomies), and menopause ≥12 months prior to the screening visit (menopause confirmed by follicle stimulating hormone (FSH) level ≥40IU/L);
For male subjects with fertile female partners, consent must be given to the use of non-drug contraception for 14 days prior to dosing, during the study period, and for 3 months after dosing. Male subjects are not allowed to donate sperm during this period;
Be willing to comply with visits, study treatments, laboratory tests, and other study-related procedures and requirements as specified in the study protocol.

Who cannot join

is allergic to the investigational drug product or its excipients, or has a history of severe allergy (including any food allergy or drug allergy);
have received antiviral therapy (ART), or been vaccinated against HIV;
Have a history of serious illness or other serious chronic diseases;
Have a history of mental illness, or have a family history of mental illness;
any of the following conditions exist: i. Unexplained persistent irregular fever above 38 °C within 1 month before or during the screening period; ii. Persistent diarrhea (more than 3 stools/day) within 1 month before or during the screening period; iii. Severe infection, opportunistic infection, or sepsis in the 6 months prior to or during the screening period;
Hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (HCV-Ab) positive;

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The 12-lead ECG was abnormal and clinically significant during screening, such as QTcF interval (Fridericia correction) > 450 ms in male and > 470 ms in female;
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times ULN, or total bilirubin > 1.5 times ULN during screening;
Serum creatinine clearance (Ccr) at screening was < 60 mL/min (calculated according to Cockcroft-Gault formula);
A known or suspected history of drug abuse (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine), or a positive baseline drug screening test;
Heavy drinking in the year before screening (drinking more than 14 standard units per week, 1 standard unit containing 14 g of alcohol, such as 5% beer 360 ml, 40% spirits 45 ml, 12% wine 120 ml); Or fail to comply with the no-alcohol policy for the duration of the study;
Smoking more than 5 cigarettes per day in the 3 months prior to screening, or failing to comply with the no-smoking policy during the study period;
have received any vaccine in the three months prior to screening, or plan to receive any vaccine during the study period;
received any investigational drug therapy or participated in any drug/investigational device trial within 3 months prior to dosing;
had undergone a major surgical procedure within 30 days prior to dosing or planned to undergo a major surgical procedure during the study period;
Those who have donated blood or lost blood ≥ 400 ml or received blood transfusion within 3 months before screening;
There are other circumstances that are not suitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Henan Provincial Hospital for Infectious Diseases (Zhengzhou Sixth People's Hospital)
Zhengzhou, Henan

Other trials in China

About this study

Official title: Clinical Trial of Safety, Pharmacodynamics and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98 in Primary Treatment of HIV-infected Patients

Read the detailed description

This is a randomized, double-blind, parallelize-designed, multicenter, exploratory clinical study to evaluate the safety, PD, and PK profile of multiple subcutaneous injections of LP-98 in HIV-infected individuals who have not received antiviral therapy.

This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.

The study included screening period (D-28~D-1), treatment period (D1-D57), and follow-up period (D58~D71).

Conditions: Hiv
Being tested: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
Keywords: LP-98, Double-Blind, Treatment-Naive HIV-Infected Individuals
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.

Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.Drug
This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.

Study groups in NCT06560489
Study group	Role	What they receive
Dose level(1.25mg)	Experimental	This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses. Receives: Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
Dose level(2.5mg)	Experimental	This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses. Receives: Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
Dose level(5mg)	Experimental	This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses. Receives: Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.
Dose level(10mg)	Experimental	This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses. Receives: Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.

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 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. Changes of this continuous curve will be recorded，To evaluate the incidence of abnormal electrocardiogram.
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.

Secondary outcomes (3)

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 71 days after the first administration.
Changes from baseline in HIV viral load detection of Laboratory Examination.
Changes of HIV viral load detection will be recorded.
Measured: Within 71 days after the first administration.
Changes from baseline in CD4+T cell counts of Laboratory Examination.
Changes of CD4+T cell counts will be recorded.
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.

2 Sep 202422 Aug 2025

First posted19 Aug 2024
Study start2 Sep 2024
Primary completion10 Jan 2025
Study completion22 Aug 2025

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06560489
Sponsor's protocol ID: KB_LP-98_102
Status last verified: Feb 2026
First submitted: 15 Aug 2024
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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: Clinical Trial of Safety, Pharmacodynamics and Pharmacokinetic Characteristics of Multiple Subcutaneous Injections of LP-98 in Primary Treatment of HIV-infected Patients
ClinicalTrials.gov ID: NCT06560489
Acronym / sponsor ID: KB_LP-98_102
Conditions: Hiv
Keywords: LP-98, Double-Blind, Treatment-Naive HIV-Infected Individuals
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Shanxi Kangbao Biological Product Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Institute of Pathogen Biology, Beijing, China
Study start: 2 Sep 2024 (actual)
Primary completion: 10 Jan 2025 (actual)
Study completion: 22 Aug 2025 (actual)
First posted: 19 Aug 2024 (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.

Detailed description

The study included screening period (D-28~D-1), treatment period (D1-D57), and follow-up period (D58~D71).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Dose level(1.25mg)	Experimental	Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.
Dose level(2.5mg)	Experimental	Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.
Dose level(5mg)	Experimental	Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.
Dose level(10mg)	Experimental	Drug: Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Voluntarily participate in the study and obtain informed consent prior to any study-related evaluation;
Aged 18-65 years at the time of the screening visit (including the cut-off), male or female;
At the time of screening visit, the weight of male subjects is not less than 50 kg and that of female subjects is not less than 45 kg;
Plasma HIV RNA level ≥1000 copies /mL, CD4+T lymphocyte count ≥200 /μL;
For female subjects: Only subjects with no reproductive potential were included, including surgical sterilization at least 6 weeks prior to the screening visit (documented hysterectomy or bilateral oopectomies), and menopause ≥12 months prior to the screening visit (menopause confirmed by follicle stimulating hormone (FSH) level ≥40IU/L);

Key exclusion criteria (17 listed)

is allergic to the investigational drug product or its excipients, or has a history of severe allergy (including any food allergy or drug allergy);
have received antiviral therapy (ART), or been vaccinated against HIV;
Have a history of serious illness or other serious chronic diseases;
Have a history of mental illness, or have a family history of mental illness;
any of the following conditions exist: i. Unexplained persistent irregular fever above 38 °C within 1 month before or during the screening period; ii. Persistent diarrhea (more than 3 stools/day) within 1 month before or during the screening period; iii. Severe infection, opportunistic infection, or sepsis in the 6 months prior to or during the screening period;

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
Subjects will be randomly assigned to receive 1.25 mg, 2.5 mg, 5 mg, or 10 mg of LP-98.This study consisted of 4 cohorts with 10 subjects in each group, who were randomly assigned to receive LP-98 treatment of 1.25 mg, 2.5 mg, 5 mg, and 10 mg. The method of administration was subcutaneous injection, and the interval of administration was 14 days, a total of 4 doses.	Drug	Dose level(1.25mg), Dose level(10mg), Dose level(2.5mg), Dose level(5mg)

Primary outcome

Changes from baseline in respiration rate of Vital Signs.
Time frame: Within 71 days after the first administration.
Respiration rate in times / minute
Changes from baseline in blood pressure of Vital Signs.
Time frame: Within 71 days after the first administration.
Blood pressure in mmHg
Changes from baseline in Blood lactate of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of blood lactate will be recorded.
Changes from baseline in body temperature of Vital Signs.
Time frame: Within 71 days after the first administration.
Body temperature in Celsius degree
Changes from baseline in red blood cell count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Red blood cell count in whole blood is reported in the form of number.
Changes from baseline in white blood cell count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
White blood cell count in whole blood is reported in the form of number.
Changes from baseline in neutrophil count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Neutrophil count in whole blood is reported in the form of number.
Changes from baseline in lymphocyte count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Lymphocyte count in whole blood is reported in the form of number.
Changes from baseline in platelet count of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Platelet count in whole blood is reported in the form of number.
Changes from baseline in hemoglobin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of hemoglobin concentration（g/dL）in whole blood will be recorded.
Changes from baseline in PT of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Prothrombin time (PT) is a screening test for exogenous coagulation factors.
Changes from baseline in INR of Laboratory Examination.
Time frame: Within 71 days after the first administration.
International standardized ratio (INR) is calculated from prothrombin time and international sensitivity index (ISI) of the reagent.
Changes from baseline in APTT of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Activated partial thromboplastin time (APTT) is a screening test for endogenous coagulation factors.
Changes from baseline in total bilirubin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of total bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in direct bilirubin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of direct bilirubin concentration (μmol/L) in serum will be recorded.
Changes from baseline in ALT of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of ALT concentration (U/L) in serum will be recorded.
Changes from baseline in AST of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of AST concentration (U/L) in serum will be recorded.
Changes from baseline in total protein of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of total protein concentration (g/L) in serum will be recorded.
Changes from baseline in albumin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of albumin concentration (g/L) in serum will be recorded.
Changes from baseline in urea of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urea concentration (mmol/L) in serum will be recorded.
Changes from baseline in creatinine of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of creatinine concentration (μmol/L) in serum will be recorded.
Changes from baseline in uric acid of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of uric acid concentration (μmol/L) in serum will be recorded.
Changes from baseline in glucose of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of glucose concentration (mmol/L) in serum will be recorded.
Changes from baseline in potassium of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of potassium concentration (mmol/L) in serum will be recorded.
Changes from baseline in sodium of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of sodium concentration (mmol/L) in serum will be recorded.
Changes from baseline in chlorine of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of chlorine concentration (mmol/L) in serum will be recorded.
Changes from baseline in urine specific gravity of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine specific gravity will be recorded.
Changes from baseline in urine pH of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine pH value will be recorded.
Changes from baseline in urine glucose of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine glucose will be examined by qualitative test (positive or negative).
Changes from baseline in urine protein of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine protein will be examined by qualitative test (positive or negative).
Changes from baseline in urine ketone body of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine ketone body will be examined by qualitative test (positive or negative).
Changes from baseline in urine white blood cell of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of white blood cell in urine will be examined by qualitative test (positive or negative).
Changes from baseline in urine bilirubin of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine bilirubin will be examined by qualitative test (positive or negative).
Changes from baseline in urine occult blood of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes of urine occult blood will be examined by qualitative test (positive or negative).
Changes from baseline in Electrocardiogram.
Time frame: Within 71 days after the first administration.
The cardiac rhythm is showed in electrocardiogram in the form of continuous curve. Changes of this continuous curve will be recorded，To evaluate the incidence of abnormal electrocardiogram.
Changes from baseline in CK of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of CK concentration (U/L) in serum will be recorded.
Changes from baseline in CK-MB of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of CK-MB concentration (ng/mL) in serum will be recorded.
Changes from baseline in LDH of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of LDH concentration (U/L) in serum will be recorded.
Changes from baseline in ALP of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of ALP concentration (U/L) in serum will be recorded.
Changes from baseline in Triglyceride of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of Triglyceride concentration (mmol/L) in serum will be recorded.
Changes from baseline in CHOL of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of CHOL concentration (mmol/L) in serum will be recorded.
Changes from baseline in TP of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of TP concentration (g/L) in serum will be recorded.
Changes from baseline in ALB of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of ALB concentration (g/L) in serum will be recorded.
Changes from baseline in UA of Laboratory Examination
Time frame: Within 71 days after the first administration.
Changes of UA concentration (μmol/L) in serum will be recorded.

3 secondary outcomes

Changes from baseline in Immunogenic blood collection of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in HIV viral load detection of Laboratory Examination.
Time frame: Within 71 days after the first administration.
Changes from baseline in CD4+T cell counts of Laboratory Examination.
Time frame: Within 71 days after the first 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 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. This study is not recruiting at the moment.

Qingxia Zhao, Doctor study director

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?

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 17 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 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?

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 71 days after the first administration.). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06560489.

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.