Experimental blood pressure pill gets first safety check in humans
NCT ID NCT07174830
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing an experimental drug called allisartan isoproxil in 54 healthy Chinese adults. Participants will receive a single dose of either the drug or a placebo to see how the body processes it and whether it causes any side effects. The goal is to gather safety and dosing information for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allisartan isoproxil (an experimental blood pressure medication)
- What this could lead to
- If successful, this study will provide key safety and dosing data to support future trials of allisartan isoproxil for high blood pressure.
- What could go wrong
- This is an early-phase study in healthy volunteers, not patients. It only tests single doses, so it cannot show whether the drug works for any condition. Side effects may still emerge.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Feb 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: * Healthy male or female adults aged 18 to 65 years (inclusive). * Body weight ≥50 kg for male participants and ≥45 kg for female participants at screening, with a body mass index (BMI) between 19.0 and 25.0 kg/m2. * Seated systolic blood pressure (SBP) ≥100 mmHg and \<140 mmHg, seated diastolic blood pressure (DBP) ≥70 mmHg and \<90 mmHg, and no orthostatic hypotension at screening. * Participants must be able to communicate effectively with the investigator, fully understand the trial's objectives and requirements, voluntarily participate in the clinical trial, and provide written informed consent. Exclusion Criteria: * Known or suspected allergy to Allisartan Isoproxil, , other ARBs, or any excipients of this formulation. * Abnormal findings in physical examination, vital signs, electrocardiogram (ECG), or laboratory tests that are clinically significant as judged by the investigator. * Any medical history or current condition that may impact participant safety assessments or the pharmacokinetics of the investigational drug, including but not limited to disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematologic system, immune system, psychiatric conditions, metabolic abnormalities, or prior gastrointestinal surgery. * Used any prescription drugs, over-the-counter medications,Chinese herbal medicines, or food supplements within 14 days prior to screening. * Participants with hyponatremia, hyperkalemia, or hypovolemia; * Participants with a history of orthostatic hypotension or syncope; * Participants who have received any vaccinations within 4 weeks prior to screening. * Participants who consume excessive amounts of strong tea, coffee, and/or caffeinated beverages (≥8 cups/day, 1 cup=250 mL), or have consumed such beverages within 48 hours prior to dosing, or cannot abstain during the trial; * Participants with habitual intake of xanthine-rich or grapefruit-containing products, or have consumed such products within 48 hours prior to dosing, or cannot abstain during the trial; * Female participants who are pregnant or breastfeeding; * Participants (or their partners/spouses) who plan pregnancy, sperm/egg donation, or refuse to use at least one acceptable contraceptive method during the trial and for 3 months post-study ; * Participants with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV antibody test, and treponema pallidum antibody test. * Heavy smokers or Participants with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study.; * Heavy drinkers or Participants with an average alcohol consumption of more than 14 units per week (1 unit=360 mL beer/45 mL 40% spirits/150 mL wine) within 3 months prior to screening, or with a positive result for breath alcohol test at screening, or those who could not completely stop consuming alcohol-containing food or beverages during the study; * Participants with a positive result for drug abuse test at screening, or a history of drug abuse(past 5 years), or recent illicit drug use (within 3 months prior to screening); * Participants who have participated in other drug/device trials and received investigational products within 3 months prior to screening; * Participants who have donated blood (≥400 mL), received transfusions, or used blood products within 3 months prior to screening; * Participants with difficult venous access or intolerance to repeated venipuncture; * Participants with difficulty swallowing study medication; Participants deemed by investigators to have poor compliance or other factors unsuitable for trial participation.
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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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Shenzhen People's Hospital
RECRUITINGShenzhen, Guangdong, China
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