NCT05130567

A Study of LP-128 Capsules in Healthy Subjects

A Randomized Study of LP-128 Capsules vs. Placebo to Evaluate Safety, Tolerability and Pharmacokinetics in Healthy Subjects

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LP-128 Capsules After Single- and Multiple-Dose in Healthy Subjects

Detailed description

This trial includes single dose and multiple dose phases. The single-dose phase included six dose cohorts. Based on the safety and pharmacokinetic results of single-dose study, approximately 2 doses will be selected to conduct multiple-dose study. The primary study objectives are to evaluate the safety, tolerability, and pharmacokinetic characteristics of LP-128 capsules in healthy subjects after single and multiple dosing.

Conditions

• Chronic Hepatitis b

Interventions

Type	Name	Description
DRUG	LP-128 capsules	Oral dosing with LP-128 capsules
OTHER	Matching Placebo	Oral dosing with placebo capsules to match LP-128 capsules.

Timeline

• Start date: 2021-11-19
• Primary completion: 2026-09-30
• Completion: 2026-12-30
• First posted: 2021-11-23
• Last updated: 2025-04-03

Locations

1 site across 1 country: China