Qilu Pharmaceutical Initiates Phase I Clinical Trial of QLS1410 Tablets for Uncontrolled Hypertension

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase I clinical study has been initiated by Qilu Pharmaceutical Co., Ltd. to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of single and multiple ascending doses of QLS1410 tablets in healthy adult participants and those with mild primary hypertension in China. The clinical trial registration number is CTR20253578, and the initial information disclosure date was September 4, 2025.

The drug formulation is tablets, with specifications of 0.5mg/tablet and 2mg/tablet. The dosage is 0.5 - 20mg, adjusted according to the trial process, administered orally, and the treatment duration is a single dose. The purpose of this trial is to evaluate the safety and tolerability of QLS1410 tablets after single and multiple dosing in adult healthy participants and those with mild primary hypertension in China.

QLS1410 Tablets are chemical drugs indicated for uncontrolled hypertension. Hypertension refers to elevated arterial blood pressure in the systemic circulation, with a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg. Common symptoms include dizziness, headache, etc., and it is typically diagnosed using a mercury sphygmomanometer or electronic blood pressure monitor.

The primary endpoint indicators of this trial include the incidence and severity of adverse events (AE); safety evaluation indicators include physical examination, vital signs, clinical laboratory tests, 12-lead electrocardiogram, and ambulatory electrocardiogram. Secondary endpoint indicators include PK parameters in plasma after single and multiple dosing, as well as relevant PK parameters under fed and fasting conditions.

Currently, the experiment status is ongoing (not yet recruiting), with a target enrollment of 78 participants.

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Editor: Xiaolang Express