NCT07152444

A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Ascending Doses of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of single and multiple ascending doses of QLS1410 in healthy Chinese adults and participants with mild essential hypertension

Detailed description

This study consists of three parts, as follows: Part A is a randomized, placebo-controlled, double-blind single ascending dose (SAD) study in healthy Chinese adults, consisting of 5 cohorts. Starting dose of 0.5 mg by oral administration are planned. Once sufficient safety and PK data are obtained from the SAD cohorts, the SMC will determine the dosage of initial cohort in Part B and Part C. Part B is a randomized, open-label, two-cycle, crossover food effect (FE) study under fasting and fed (high-fat meal) conditions. Part C is a randomized, placebo-controlled, double-blind multiple ascending doses (MAD) study in participants with mild essential hypertension, consisting of 3 cohorts.

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DRUG	QLS1410 (CYP11B2 inhibitor)	QLS1410 tablets
DRUG	placebo	Matching placebo tablets

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: China