Healthy ParticipantsPhase 4NCT07174830
Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants
A Phase 4 study of Healthy Participants, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2025to 16 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong
Hongying Yang, M.D., 0755-22942636, yanghy0119@163.com
Hongying Yang, M.D.
About this study
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.
Read the detailed description
This study will be conducted at 1 study center in Shenzhen. 18 healthy Chinese male and female participants per group, aged 18 to 65 inclusive, will be randomized in a 5:1 ratio to receive a single administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg）or placebo (54 participants in total). Each participant will participate in only 1 treatment group. Blood samples will be collected up to 72 hours post-dose for pharmacokinetic parameter calculation, and safety monitoring will continue until sample collection is complete.
- Conditions
- Healthy Participants
- Being tested
- Allisartan Isoproxil Tablets 240mg or placebo, Allisartan Isoproxil Tablets 480mg or placebo, Allisartan Isoproxil Tablets 720mg or placebo
- Keywords
- Allisartan Isoproxil Tablets, safety, tolerability, PK profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allisartan Isoproxil Tablets 240mg or placeboDrug
Allisartan Isoproxil Tablets 240mg or placebo, QD
Allisartan Isoproxil Tablets 480mg or placeboDrug
Allisartan Isoproxil Tablets 480mg or placebo, QD
Allisartan Isoproxil Tablets 720mg or placeboDrug
Allisartan Isoproxil Tablets 720mg or placebo, QD
| Study group | Role | What they receive |
|---|---|---|
| Allisartan Isoproxil Tablets 240mg | Active comparator | Allisartan Isoproxil Tablets 240mg, QD Receives: Drug: Allisartan Isoproxil Tablets 240mg or placebo |
| Allisartan Isoproxil Tablets 480mg | Active comparator | Allisartan Isoproxil Tablets 480mg, QD Receives: Drug: Allisartan Isoproxil Tablets 480mg or placebo |
| Allisartan Isoproxil Tablets 720mg | Active comparator | Allisartan Isoproxil Tablets 720mg, QD Receives: Drug: Allisartan Isoproxil Tablets 720mg or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events during the whole study
Measured: up to Day 4
Cmax
Observed maximum plasma concentration (Cmax)
Measured: Day 1 to Day 4
AUC0-t
Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t)
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start6 Sep 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion16 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongying Yang, M.D., Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174830
- Sponsor's protocol ID
- SAL065A401
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Allisartan Isoproxil Tablets in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07174830
- Acronym / sponsor ID
- SAL065A401
- Conditions
- Healthy Participants
- Keywords
- Allisartan Isoproxil Tablets, safety, tolerability, PK profile
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 16 Feb 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be conducted at 1 study center in Shenzhen. 18 healthy Chinese male and female participants per group, aged 18 to 65 inclusive, will be randomized in a 5:1 ratio to receive a single administration of Allisartan Isoproxil Tablets (240 mg ,480 mg or 720 mg）or placebo (54 participants in total). Each participant will participate in only 1 treatment group. Blood samples will be collected up to 72 hours post-dose for pharmacokinetic parameter calculation, and safety monitoring will continue until sample collection is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allisartan Isoproxil Tablets 240mg | Active comparator | Drug: Allisartan Isoproxil Tablets 240mg or placeboAllisartan Isoproxil Tablets 240mg, QD |
| Allisartan Isoproxil Tablets 480mg | Active comparator | Drug: Allisartan Isoproxil Tablets 480mg or placeboAllisartan Isoproxil Tablets 480mg, QD |
| Allisartan Isoproxil Tablets 720mg | Active comparator | Drug: Allisartan Isoproxil Tablets 720mg or placeboAllisartan Isoproxil Tablets 720mg, QD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allisartan Isoproxil Tablets 240mg or placeboAllisartan Isoproxil Tablets 240mg or placebo, QD | Drug | Allisartan Isoproxil Tablets 240mg |
| Allisartan Isoproxil Tablets 480mg or placeboAllisartan Isoproxil Tablets 480mg or placebo, QD | Drug | Allisartan Isoproxil Tablets 480mg |
| Allisartan Isoproxil Tablets 720mg or placeboAllisartan Isoproxil Tablets 720mg or placebo, QD | Drug | Allisartan Isoproxil Tablets 720mg |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: up to Day 4
Incidence of treatment-emergent adverse events during the whole study
Cmax
Time frame: Day 1 to Day 4
Observed maximum plasma concentration (Cmax)
AUC0-t
Time frame: Day 1 to Day 4
Plasma concentration-time curve from time zero extrapolated to the time of last quantifiable concentration (AUC0-t)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongying Yang, M.D. principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Healthy Participants, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongying Yang, M.D. (0755-22942636, yanghy0119@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: up to Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.