Uncontrolled HypertensionPhase 1NCT07152444
A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension
A Phase 1 study testing QLS1410 (CYP11B2 inhibitor) in people with Uncontrolled Hypertension, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- QLS1410 (CYP11B2 inhibitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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):
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
Read the 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
- Being tested
- QLS1410 (CYP11B2 inhibitor), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1410 (CYP11B2 inhibitor)Drug
QLS1410 tablets
placeboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| QLS1410 | Experimental | Part A: Healthy adults will be randomized (6:2) to receive a single dose (1.5 mg ~ 20 mg) of QLS1410 or placebo,especially, the starting dose will be 0.5 mg of QLs1410
Part B: QLS1410 will be administered under the fasted or fed conditions in two different periods separated by a wash-out interval of 14 days. The dose of QLS1410 or placebo is based on upcoming data from SAD part.
Part C: Hypertensive participants will be randomized (8:2) to receive QLS1410 or placebo QD for 14 continuous days. The starting dose of QLS1410 or placebo is based on upcoming data from SAD part. Receives: Drug: QLS1410 (CYP11B2 inhibitor) |
| Placebo | Placebo comparator | Part A: Healthy adults will be randomized (6:2) to receive a single dose (1.5 mg ~ 20 mg) of QLS1410 or placebo
Part B: QLS1410 will be administered under the fasted or fed conditions in two different periods separated by a wash-out interval of 14 days. The dose of QLS1410 or placebo is based on upcoming data from SAD part.
Part C: Hypertensive participants will be randomized (8:2) to receive QLS1410 or placebo QD for 14 continuous days. The starting dose of QLS1410 or placebo is based on upcoming data from SAD part. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
Measured: up to approximately 1 month
Secondary outcomes (7)
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Measured: up to approximately 1 month
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]
Measured: up to approximately 1 month
Maximum observed plasma concentration (Cmax)
Measured: up to approximately 1 month
Terminal elimination half-life (t1/2)
Measured: up to approximately 1 month
Apparent clearance (CL/F)
Measured: up to approximately 1 month
Apparent volume of distribution (Vz/F)
Measured: up to approximately 1 month
Mean residence time (MRT)
Measured: up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152444
- Sponsor's protocol ID
- QSL1410-101
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07152444
- Acronym / sponsor ID
- QSL1410-101
- Conditions
- Uncontrolled Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS1410 | Experimental | Drug: QLS1410 (CYP11B2 inhibitor)Part A: Healthy adults will be randomized (6:2) to receive a single dose (1.5 mg ~ 20 mg) of QLS1410 or placebo,especially, the starting dose will be 0.5 mg of QLs1410 Part B: QLS1410 will be administered under the fasted or fed conditions in two different periods separated by a wash-out interval of 14 days. The dose of QLS1410 or placebo is based on upcoming data from SAD part. Part C: Hypertensive participants will be randomized (8:2) to receive QLS1410 or placebo QD for 14 continuous days. The starting dose of QLS1410 or placebo is based on upcoming data from SAD part. |
| Placebo | Placebo comparator | Drug: placeboPart A: Healthy adults will be randomized (6:2) to receive a single dose (1.5 mg ~ 20 mg) of QLS1410 or placebo Part B: QLS1410 will be administered under the fasted or fed conditions in two different periods separated by a wash-out interval of 14 days. The dose of QLS1410 or placebo is based on upcoming data from SAD part. Part C: Hypertensive participants will be randomized (8:2) to receive QLS1410 or placebo QD for 14 continuous days. The starting dose of QLS1410 or placebo is based on upcoming data from SAD part. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS1410 (CYP11B2 inhibitor)QLS1410 tablets | Drug | QLS1410 |
| placeboMatching placebo tablets | Drug | Placebo |
Primary outcome
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
Time frame: up to approximately 1 month
7 secondary outcomes
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Time frame: up to approximately 1 month
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]
Time frame: up to approximately 1 month
Maximum observed plasma concentration (Cmax)
Time frame: up to approximately 1 month
Terminal elimination half-life (t1/2)
Time frame: up to approximately 1 month
Apparent clearance (CL/F)
Time frame: up to approximately 1 month
Apparent volume of distribution (Vz/F)
Time frame: up to approximately 1 month
Mean residence time (MRT)
Time frame: up to approximately 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS1410 (CYP11B2 inhibitor) in people with Uncontrolled Hypertension, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Li, B.M (18600489179, haiyanli1027@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0 (time frame: up to approximately 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.