NCT07254481

VB19055 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

A Phase 1, Randomized, Double-Blind Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Food Effects, and QT/QTc Interval Impact of VB19055 Tablets in Healthy Chinese Adult Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of VB19055 in the healthy Chinese population.

Detailed description

This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects. Part A is a single ascending dose study of VB19055 tablets in healthy Chinese adult participants. Part B is a randomized, single-dose, two-period, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of VB19055 tablets in healthy Chinese adult participants.Part C is a multiple ascending dose study of VB19055 tablets in healthy Chinese adult participants. Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	VB19055	In this part, VB19055 tablets will be administered as a single or multiple oral dose.
DRUG	VB19055 placebo	In this part, VB19055 placebo tablets will be administered as a single or multiple oral dose.

Timeline

• Start date: 2025-10-05
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

2 sites across 1 country: China