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Uncontrolled HypertensionPhase 1NCT07051603

SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

A Phase 1 study testing SAL0140 in people with Uncontrolled Hypertension, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population. 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?
SAL0140
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteChina
Study dates
9 Jun 2025to Feb 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

  • Subjects has fully understood and voluntarily signed the informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;
  • Male or female aged 18-65 years (including 18 and 65 years old);
  • Male body weight ≥50kg, female body weight ≥45kg and body mass index (BMI) between 19.0 - 26.0 kg/m2 (including 19.0 and 26.0, BMI = weight(kg) / height(cm)2) at screening;
  • All examinations (including physical examination, vital signs, laboratory tests, ECG, chest X-ray (anterior and lateral views), etc.) show no abnormalities or minor abnormalities deemed non clinical signiant by the investigator;

Who cannot join

  • Subjects with orthostatic tachycardia or orthostatic hypotension at screening; or those with a history of orthostatic hypotension symptoms (such as dizziness, fatigue, blurred vision, pallor upon standing) or orthostatic tachycardia symptoms (such as dizziness, palpitations, tremors, general weakness, blurred vision, exercise intolerance when standing);
  • Subjects have used corticosteroids within 3 months prior to dosing;
  • Subjects with personal or family history of long QT syndrome, torsades de pointes, or other complex arrhythmias, or family history of sudden death;
  • Subjects with prolonged QTcF interval (>450msec) on ECG;
  • Subjects with potassium levels above the upper limit of normal (>ULN) or sodium levels below the lower limit of normal (<LLN) in biochemistry tests;
  • Subjects with known allergies to excipients in the study drug or history of severe allergic reactions (including food, drugs, insect bites, etc.);
Show all 25Show fewer
  • Subjects with any disease history or current condition that may affect the safety evaluation or drug disposition of the study participant, including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, psychiatric conditions, metabolic disorders, gastrointestinal surgery (except appendectomy), etc.;
  • Subjects have undergone gastric surgery, vagotomy, bowel resection, or any surgery that may interfere with gastrointestinal motility, pH, or absorption;
  • Subjects received live or attenuated vaccines within 4 weeks prior to screening;
  • Subjects consume excessive tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) daily, or have consumed these beverages within 48h prior to dosing, or cannot stop consuming during the trial;
  • Subjects have taken any prescription drugs, over-the-counter medications, Chinese herbs, or dietary supplements (including vitamins, health foods, etc.) within 14 days prior to dosing;
  • Subjects with a history of long-term consumption of xanthine-rich or grapefruit-containing beverages or foods, or who have consumed any xanthine-rich or grapefruit products within 48h prior to dosing;
  • Subjects have smoked within 3 months prior to screening, or cannot stop using any tobacco products during the trial;
  • Subjects have participated in other clinical trials and taken any investigational drugs within 3 months prior to screening;
  • Subjects have donated blood or lost blood ≥400 mL, received blood transfusion or blood products within 3 months prior to screening;
  • Subjects have had unprotected sexual intercourse within 2 weeks prior to screening; study participants and their spouses or partners who have pregnancy plans, sperm/egg donation plans during the study period until 1 month after dosing, or do not agree to use at least one of the following acceptable effective contraception methods:
  • Correctly placed intrauterine device;
  • Male/female condom used in combination with topical spermicide (i.e., foam, gel, film, cream, or suppository);
  • Male vasectomy or vas deferens ligation;
  • Female bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion surgery (occlusion surgery verified effective by relevant instruments);
  • Abstinence.
  • Pregnant or lactating women, or women of childbearing potential with positive pregnancy screening results;
  • Subjects are alcoholic or regular drinkers within 3 months prior to screening, i.e., weekly alcohol consumption exceeding 14 standard units (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine) or positive baseline alcohol breath test, or cannot stop using any alcohol-containing products during the trial;
  • Subjects positive drug abuse screening or history of drug abuse or previous use of illicit drugs;
  • Subjects tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody; Subjects deemed by the investigator to have poor compliance or other factors that unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chongyuan Xu, Ph.D. contact

13926186470

nflcyljd@smu.edu.cn

China1 site, 1 recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

    Chongyuan Xu, Ph.D, 13926186470, nflcyljd@smu.edu.cn

    Chongyuan Xu, Ph.D

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Randomized, Double-Blind Placebo-Controlled Single and Multiple Dose Study Plus Food Effect Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SAL0140 in Healthy Chinese Subjects

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.

Read the detailed description

This trial contains Part A, Part B and Part C, all enrolling healthy Chinese subjects. Part A is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of SAL0140 tablets in healthy Chinese adult participants. Part B is a randomized, open-label, single-dose, two-period, two-sequence, crossover study designed to evaluate the effect of food on the pharmacokinetic characteristics of SAL0140 tablets in healthy Chinese adult participants. Part C is a randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of SAL0140 tablets in healthy Chinese adult participants.

Part A will be conducted first, and Parts B and C will be initiated when appropriate based on the preliminary data obtained during the study. Each participant can only participate in one dose group in any part of the study after dosing.

Being tested
SAL0140, SAL0140 placebo
Keywords
SAL0140, Uncontrolled hypertension, Pharmacokinetic, Pharmacodynamic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAL0140Drug

    In this part, SAL0140 tablets will be administered as a single or multiple oral dose.

  • SAL0140 placeboDrug

    In this part, SAL0140 placebo tablets will be administered as a single or multiple oral dose.

Study groups in NCT07051603
Study groupRoleWhat they receive
Single Ascending Doses (SAD, Part A)ExperimentalIn this part, 5 ascending dose cohorts (8 participants per cohort) will be studied. Within each cohort, participants will be randomized in a 6:2 ratio to receive either SAL0140 or placebo.
Receives: Drug: SAL0140; Drug: SAL0140 placebo
Experimental: Foode Effect (FE, Part B)Experimental12 participants and single dose food effect cohort. This part is open-label, two sequence, two-period, crossover design. Participants will be randomly assigned to 1 of the 2 crossover sequence
Receives: Drug: SAL0140
Experimental: Single Ascending Doses (MAD, Part C)ExperimentalIn this part, 3 ascending dose cohorts (10 participants per cohort) will be studied. Within each cohort, participants will be randomized in an 8:2 ratio to receive either SAL0140 or placebo.
Receives: Drug: SAL0140; Drug: SAL0140 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of Adverse events

    The rate of Adverse events occur during the whole study

    Measured: from Day 1 to Day8 or Day23 or Day28

  2. The rate of normality or abnormality of electrocardiogram

    The rate of normality or abnormality of electrocardiogram during the whole study

    Measured: from Day 1 to Day8 or Day23 or Day28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2025
  2. Study start9 Jun 2025
  3. Primary completionJan 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

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
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07051603
Sponsor's protocol ID
SAL0140A101
Status last verified
Jun 2025
First submitted
17 Jun 2025
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAL0140 in people with Uncontrolled Hypertension, run by Shenzhen Salubris Pharmaceuticals 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 4 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 4 Jul 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. 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 Chongyuan Xu, Ph.D. (13926186470, nflcyljd@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of Adverse events (time frame: from Day 1 to Day8 or Day23 or Day28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07051603.

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 4 Jul 2025.

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