NCT07030504

To Evaluate the Safety, Tolerability and Pharmacokinetic of SAL0133 Tablets in Chinese Adult Healthy Subjects

The Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of SAL0133 Tablets in Chinese Adult Healthy Subjects

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and tolerance of single and multiple administrations of SAL0133 tablets in adult healthy subjects in China receptivity.

Detailed description

This study was divided into two parts: Part A and Part B. Part A was single-center, randomized, double-blind, and placebo control, single-dose escalation study (SAD) was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after a single dose. Furthermore, food effect would be preliminarily evaluated the influence of the pharmacokinetic characteristics of SAL0133 tablets in Part A. Part B was a single-center, randomized, double-blind, placebo controlled, multiple-dose escalation study was conducted to evaluate the safety, tolerability and pharmacokinetic characteristics of SAL0133 tablets after multiple doses.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	SAL0133	once daily single dose or seven days multiple dose of SAL0133 tables
DRUG	SAL0133 placebo	once daily single dose or seven days multiple dose of SAL0133 placebo

Timeline

• Start date: 2023-01-10
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: China