Exploratory Study of LP-98 for Injection in ART-Naive HIV-Infected Individuals

NCT07433387 | Recruiting Phase 1

• 1 other identifier: KB_LP-98_103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HIV

Keywords

LP-98

Outcome Measures

Primary Outcomes (5)

• Plasma HIV RNA levels (log10 copies/mL) and changes from baseline

  Changes of HIV viral load detection will be recorded.

  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.

  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.

  Within 71 days after the first administration.

• Absolute CD4+ T lymphocyte count and change from baseline

  Changes of CD4+T counts will be recorded.

  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.

  Within 71 days after the first administration.

Secondary Outcomes (47)

• Changes from baseline in respiration rate of Vital Signs.

  Within 71 days after the first administration.

• Changes from baseline in blood pressure of Vital Signs.

  Within 71 days after the first administration.

• Changes from baseline in Blood lactate of Laboratory Examination.

  Within 71 days after the first administration.

• Changes from baseline in body temperature of Vital Signs.

  Within 71 days after the first administration.

• Changes from baseline in red blood cell count of Laboratory Examination.

  Within 71 days after the first administration.

Study Arms (3)

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.

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.

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.

Drug: LP-98 80 mg

Interventions

LP-98 20 mg DRUG

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 20 mg dose group

LP-98 40 mg DRUG

LP-98 40 mg

LP-98 40 mg dose group

LP-98 80 mg DRUG

LP-98 80 mg

LP-98 80 mg dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• ）Persistent unexplained fever above 38°C within 1 month prior to screening or during the screening phase.
• ）Persistent diarrhea (more than 3 bowel movements per day) within 1 month prior to screening or during the screening phase.
• ）Severe infections, opportunistic infections, or sepsis within 6 months prior to screening or during the screening phase.
• 、Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
• 、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.
• 、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.
• 、Serum creatinine clearance (Ccr) \< 60 mL/min at screening (calculated using the Cockcroft-Gault formula).
• 、Known or suspected history of drug abuse (including morphine, methamphetamine, ketamine, dimethylthioamphetamine, tetrahydrocannabinolic acid, cocaine), or a positive baseline drug screening test.
• 、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.
• 、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.

Sponsors & Collaborators

• Shanxi Kangbao Biological Product Co., Ltd.: lead
• Institute of Pathogen Biology, Beijing, China: collaborator

Study Sites (1)

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Study Officials

• Ping Ma, Doctor

  Tianjin Second People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuxian He, Doctor

CONTACT

+8613126823610; yhe@ipb.pumc.edu.cn

Fan Wang

CONTACT

+8618534115213; wangfan3063@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 25, 2026
• Study Start: January 29, 2026
• Primary Completion: July 10, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-04

Locations

CN (1)