RecruitingPhase 1Phase 2NCT07433387

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

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

Sponsor

Shanxi Kangbao Biological Product Co., Ltd.

Enrollment

30 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

HIV

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new injectable HIV treatment called LP-98 in people who have never previously been treated for HIV, to evaluate its safety and how well it works in controlling the virus. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with HIV and have never started antiretroviral (HIV) treatment - You meet minimum weight requirements (at least 50 kg for men, 45 kg for women) - You are willing to participate and have provided consent **You may NOT be eligible if...** - You have previously received HIV treatment - You have significant liver, kidney, or immune conditions beyond HIV - You are pregnant or breastfeeding - You have other serious health conditions that would make the study unsafe for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLP-98 20 mg

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.

DRUGLP-98 40 mg

LP-98 40 mg

DRUGLP-98 80 mg

LP-98 80 mg

Locations(1)

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

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NCT07433387

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