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Experimental blood pressure pill gets first safety check in humans

NCT ID NCT07174830

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, Guangdong, China

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