NCT07051603

SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

A Phase 1, Randomized, Double-Blind Placebo-Controlled Single and Multiple Dose Study Plus Food Effect Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SAL0140 in Healthy Chinese Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.

Detailed description

This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of SAL0140 tablets in healthy Chinese adult participants. Part B is a randomized, open-label, single-dose, two-period, two-sequence, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of SAL0140 tablets in healthy Chinese adult participants. Part C is a randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of SAL0140 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. Each participant can only participate in one dose group in any part of the study after dosing.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DRUG	SAL0140	In this part, SAL0140 tablets will be administered as a single or multiple oral dose.
DRUG	SAL0140 placebo	In this part, SAL0140 placebo tablets will be administered as a single or multiple oral dose.

Timeline

• Start date: 2025-06-09
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

1 site across 1 country: China