BridgeMD
Tests treatment safety and results for Uncontrolled Hypertension
Official title SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population
ClinicalTrials.gov ID: NCT07051603
What this study is testing
What is SAL0140?
SAL0140 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for uncontrolled hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- people has fully understood and voluntarily signed the informed consent form, and is able to comply with the requirements and restrictions listed in...
- 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) /...
- All examinations (including physical examination, vital signs, laboratory tests, ECG, chest X-ray (anterior and lateral views), etc.) show no...
You likely can't join if
- people with orthostatic tachycardia or orthostatic hypotension at screening; or those with a history of orthostatic hypotension symptoms (such as...
- people have used corticosteroids within 3 months prior to dosing;
- people with personal or family history of long QT syndrome, torsades de pointes, or other complex arrhythmias, or family history of sudden death;
- people with prolonged QTcF interval (\>450msec) on ECG;
- people with potassium levels above the upper limit of normal (\>ULN) or sodium levels below the lower limit of normal (\<LLN) in biochemistry tests;
- people with known allergies to excipients in the study drug or history of severe allergic reactions (including food, drugs, insect bites, etc.);
See the full eligibility criteria
- people 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...
- people 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...
- people have used corticosteroids within 3 months prior to dosing;
- people with personal or family history of long QT syndrome, torsades de pointes, or other complex arrhythmias, or family history of sudden death;
- people with prolonged QTcF interval (\>450msec) on ECG;
- people with potassium levels above the upper limit of normal (\>ULN) or sodium levels below the lower limit of normal (\<LLN) in biochemistry tests;
- people with known allergies to excipients in the study drug or history of severe allergic reactions (including food, drugs, insect bites, etc.);
- people 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...
- people have undergone gastric surgery, vagotomy, bowel resection, or any surgery that may interfere with gastrointestinal motility, pH, or absorption;
- people received live or attenuated vaccines within 4 weeks prior to screening;
- people 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;
- people 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;
- people 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;
- people have smoked within 3 months prior to screening, or cannot stop using any tobacco products during the trial;
- people have participated in other clinical trials and taken any investigational drugs within 3 months prior to screening;
- people have donated blood or lost blood ≥400 mL, received blood transfusion or blood products within 3 months prior to screening;
- people 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...
- 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;
- people 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)...
- people positive drug abuse screening or history of drug abuse or previous use of illicit drugs;
- people tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody; people deemed by the investigator to have poor compliance or other factors...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.