New blood pressure drug QLS1410 enters first human tests
NCT ID NCT07152444
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial will test a new drug called QLS1410 in 78 healthy adults and people with mild high blood pressure. The main goal is to check safety and how the body processes the drug. Researchers will also look at how food affects the drug and whether it lowers blood pressure. This is a first step to see if the drug is safe enough for larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLS1410 (a drug that blocks an enzyme involved in blood pressure regulation)
- What this could lead to
- If successful, this could lead to a new treatment option for people with mild high blood pressure.
- What could go wrong
- This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. The drug may not work as hoped or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Weight ≥ 50 kg for males and ≥ 45 kg for females, BMI between 18 and 28 kg/m\^2, inclusive, at screening. * Has a mean seated office SBP 140\~159 mmHg (inclusive) and DBP 85\~99 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals). * QTcF \<450 ms for males and \<470 ms for females. * No use of antihypertensive medications (including ACEIs, ARBs, CCBs, ARNIs, diuretics, etc.) within 30 days prior to signing the ICF. * 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. 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. * Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization. * Pregnant/lactating females or positive pregnancy test at screening. * Inability to tolerate a high-fat meal (for Part B only). Part C: Participants with Mild Essential Hypertension * Secondary hypertension. * Orthostatic tachycardia or hypotension at screening, or history of related symptoms (e.g., dizziness, weakness, blurred vision upon standing). * History of syncope. * Metabolic/cardiovascular disorders: 1) Diabetes (fasting glucose ≥7.0 mmol/L \[126 mg/dL\] or HbA1c ≥6.5%); 2) History of cardiovascular events (e.g., stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, heart failure hospitalization) or clinically significant valvular disease; 3) Personal/family history of long QT syndrome, torsades de pointes (TdP), arrhythmias, or sudden cardiac death; 4) Other conditions that may interfere with the study or increase risk, per investigator judgment. * Laboratory abnormalities (as defined in Part A/B, with repeat testing allowed). * Any other condition deemed unsuitable by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
Beijing, China
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