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A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

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

NCT07152444•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part A \& Part B: Healthy Participants
•Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
•Males and females aged 18 to 55 years, inclusive.
•Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m\^2, inclusive, at screening.
•Has a mean seated office systolic blood pressure (SBP) 110\~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70\~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
•QTcF (QT corrected using Fridericia's formula) \<450 ms for males and \<470 ms for females.
•Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.
•Part C: Participants with Mild Essential Hypertension
•Able to understand and willing to comply with all study visits, procedures, restrictions and provide the ICF.
•Males and females aged 18 to 65 years (18 to 65 years in MAD study), inclusive.
+5 more criteria

Exclusion Criteria

•Part A \& Part B: Healthy Participants
•Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the nervous, psychiatric, cardiovascular, hematologic/lymphatic, immune, respiratory, digestive, urinary, metabolic and skeletal systems.
•Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
•Use of systemic corticosteroids within 3 months prior to screening.
•Mean pulse/heart rate (HR) \>100 or \<50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
•Any laboratory abnormalities that meet the test requirements should be noted during screening (if necessary, retest can be conducted at least one week apart):
•Smoking \>5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
•Alcohol consumption \>14 units/week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening, or has a positive breath alcohol test at screening.
•Blood donation \>400 mL within 3 months or \>200 mL within 4 weeks before screening, or plan to donate blood during the study.
•Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.
+10 more criteria

Locations (1)

Peking University Third Hospital

Beijing, China

Key Dates

Start Date

September 1, 2025

Primary Completion Date

May 1, 2026

Completion Date

July 1, 2026

Last Updated

September 3, 2025

Enrollment

ESTIMATED participants

Conditions

Uncontrolled Hypertension

Interventions

QLS1410 (CYP11B2 inhibitor)

DRUG

placebo

DRUG

Contacts

Haiyan Li, B.M

CONTACT

18600489179 haiyanli1027@hotmail.com

Cheng Cui, M.D

CONTACT

13011825605 cuicheng1226@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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