NCT07433387

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanxi Kangbao Biological Product Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	LP-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.
DRUG	LP-98 40 mg	LP-98 40 mg
DRUG	LP-98 80 mg	LP-98 80 mg

Timeline

• Start date: 2026-01-29
• Primary completion: 2026-07-10
• Completion: 2026-09-25
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: China