Allisartan Isoproxil single-dose pharmacokinetics in healthy Chinese adults

Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants

We will test single doses of Allisartan Isoproxil (240, 480, 720 mg) versus placebo in healthy Chinese adults to see how the drug is absorbed and tolerated.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07174830 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, dose-escalation single-dose pharmacokinetic trial conducted at one center in Shenzhen. A total of 54 healthy Chinese men and women (18 per dose group) will be randomized 5:1 to receive Allisartan Isoproxil (240 mg, 480 mg, or 720 mg) or placebo, with each participant in only one dose group. Blood samples will be collected up to 72 hours after dosing to calculate PK parameters, and safety and tolerability will be monitored throughout the sampling period. Eligible participants are aged 18–65 with specified weight and BMI limits and must meet screening vital sign, ECG, and laboratory criteria.

Who should consider this trial

Good fit: Healthy Chinese adults aged 18–65 with BMI 19.0–25.0 kg/m2 and minimum weight thresholds (≥50 kg for men, ≥45 kg for women) who meet screening vitals and lab criteria and can give informed consent are ideal candidates.

Not a fit: Individuals with known allergy to allisartan or other ARBs, clinically significant abnormal labs or ECG, relevant medical history, or those outside the weight/BMI limits are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could define safe single-dose exposure and support dosing and safety guidance for future patient studies or clinical use.

How similar studies have performed: Single-dose PK and safety studies of other angiotensin receptor blockers in healthy volunteers have reliably informed dosing, though published data specific to allisartan isoproxil are limited.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong

• Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Hongying Yang, M.D. — Shenzhen People's Hospital
• Study coordinator: Hongying Yang, M.D.

Conditions Healthy Participants; Allisartan Isoproxil Tablets; safety; tolerability; PK profile