Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants

NCT07174830 | Recruiting Phase 4

• 1 other identifier: SAL065A401
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, dose-escalation study in healthy Chinese subjects at single dose administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg）or placebo. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of Allisartan Isoproxil Tablets.

Conditions

Healthy Participants

Keywords

Allisartan Isoproxil Tablets; safety; tolerability; PK profile

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent adverse events

  Incidence of treatment-emergent adverse events during the whole study

  up to Day 4

• Cmax

  Observed maximum plasma concentration (Cmax)

  Day 1 to Day 4

• AUC0-t

  Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t)

  Day 1 to Day 4

Study Arms (3)

Allisartan Isoproxil Tablets 240mg

ACTIVE COMPARATOR

Allisartan Isoproxil Tablets 240mg, QD

Drug: Allisartan Isoproxil Tablets 240mg or placebo

Allisartan Isoproxil Tablets 480mg

ACTIVE COMPARATOR

Allisartan Isoproxil Tablets 480mg, QD

Drug: Allisartan Isoproxil Tablets 480mg or placebo

Allisartan Isoproxil Tablets 720mg

ACTIVE COMPARATOR

Allisartan Isoproxil Tablets 720mg, QD

Drug: Allisartan Isoproxil Tablets 720mg or placebo

Interventions

Allisartan Isoproxil Tablets 240mg or placebo DRUG

Allisartan Isoproxil Tablets 240mg or placebo, QD

Allisartan Isoproxil Tablets 240mg

Allisartan Isoproxil Tablets 480mg or placebo DRUG

Allisartan Isoproxil Tablets 480mg or placebo, QD

Allisartan Isoproxil Tablets 480mg

Allisartan Isoproxil Tablets 720mg or placebo DRUG

Allisartan Isoproxil Tablets 720mg or placebo, QD

Allisartan Isoproxil Tablets 720mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Interventions

allisartan isoproxil

Study Officials

• Hongying Yang, M.D.

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongying Yang, M.D.

CONTACT

0755-22942636; yanghy0119@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 16, 2025
• Study Start: September 6, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 16, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)