Uncontrolled HypertensionPhase 1NCT07358858
A Food Effect Study of QLS1410 in Healthy Chinese Adults
A Phase 1 study testing QLS1410 in people with Uncontrolled Hypertension, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- QLS1410
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2026to 7 Feb 2026
- Phase
- Phase 1
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.
- 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.
- Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
- Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.
- Mean pulse >100 or <50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
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- Any of the following laboratory abnormalities at screening: ALT or AST >1.5 x upper limit of normal (ULN); Total bilirubin >1.5 x ULN (participants with Gilbert's syndrome may qualify if direct bilirubin ≤ULN); Creatinine >ULN or eGFR <90 mL/min/1.73 m²; Serum potassium >ULN or sodium <135 mmol/L.
- Smoking >5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
- Alcohol consumption >14 units/week (1 unit = 357 mL of 3.5% beer, 27 mL of 40% spirits, or 104 mL of 12% 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Two-period, Crossover Food Effect Study of QLS1410 in Healthy Chinese Adults
This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.
Read the detailed description
All the qualified participants will be randomized (1:1) to two treatment sequences (fed/fasting and fasting/fed). In each period, participants will receive a single dosing of QLS1410 tablets either with or without a high-fat breakfast. There will be a one-week washout period in this study.
- Conditions
- Uncontrolled Hypertension
- Being tested
- QLS1410
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1410Drug
QLS1410 tablets
| Study group | Role | What they receive |
|---|---|---|
| QLS1410 20mg | Experimental | Not described Receives: Drug: QLS1410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
Measured: 0 to 96 hours
Area under the curve plasma concentration from time zero to Time of Last Quantifiable Concentration
Measured: 0 to 96 hours
Maximum observed plasma concentration
Measured: 0 to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start23 Jan 2026 (estimated)
- Primary completion7 Feb 2026 (estimated)
- Study completion7 Feb 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
- Not applicable
- Intervention model
- Single group
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT07358858
- Sponsor's protocol ID
- QSL1410-102
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No