NCT06560489

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shanxi Kangbao Biological Product Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-02
• Primary completion: 2025-01-10
• Completion: 2025-08-22
• First posted: 2024-08-19
• Last updated: 2026-02-06

Locations

1 site across 1 country: China