Heart FailurePhase 1NCT07601087
A Clinical Study of HRS-7156 in Healthy Participants
A Phase 1 study testing HRS-7156 in people with Heart Failure, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- HRS-7156
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to Sep 2026
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged 18 to 55 years old at informed consent signing;
- Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 kg/m² at screening and baseline;
- Have no clinically significant abnormalities at screening and baseline;
- Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 1 week after the last dose (abstinence or highly effective contraception); no sperm/egg donation.
Who cannot join
- A history or current severe diseases of multiple systems, or other diseases interfering with trial results;
- Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial;
- Blood donation/severe blood loss (≥400 mL) within 8 weeks, blood transfusion within 4 weeks before screening; planned blood donation during the trial;
- History of drug abuse/dependence; positive urine drug test at screening.Participation in other clinical trials within 3 months before screening or planned;
- participation during the trial; within 5 half-lives of a prior drug (whichever is longer);
- Smoking history (≥5 cigarettes/day) within 4 weeks before screening; inability to abstain from tobacco during the trial; positive smoke screening at screening/baseline;
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- Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening;
- Special dietary requirements and inability to comply with the unified diet;
- Difficulty in swallowing/venous blood collection; intolerance to intensive blood sampling;
- Other circumstances deemed unsuitable for trial participation by Researcher.
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
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Xuening Li, +86-021-31587862, li.xuening@zs-hospital.sh.cn
Xuening Li
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of HRS-7156 in Healthy Participants
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
- Conditions
- Heart Failure
- Being tested
- HRS-7156, HRS-7156 placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7156Drug
HRS-7156, specified dose on specified day.
HRS-7156 placeboDrug
HRS-7156 placebo, specified dose on specified day.
| Study group | Role | What they receive |
|---|---|---|
| HRS-7156 | Experimental | Not described Receives: Drug: HRS-7156 |
| HRS-7156 placebo | Placebo comparator | Not described Receives: Drug: HRS-7156 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE) and serious adverse event (SAE)
Safety: Incidence of adverse event (AE) and serious adverse event (SAE).
Measured: Up to 14 days.
Secondary outcomes (5)
Area under the concentration time curve (AUC)
Pharmacokinetics (PK) parameter of HRS-7156.
Measured: Day 1 - Day 9.
Maximum Plasma Concentration (Cmax)
Pharmacokinetics (PK) parameter of HRS-7156.
Measured: Day 1 - Day 9.
Time to maximum plasma concentration (Tmax)
Pharmacokinetics (PK) parameter of HRS-7156.
Measured: Day 1 - Day 9.
Renal clearance (CLR)
Pharmacokinetics (PK) parameter of HRS-7156.
Measured: Day 1 - Day 2.
Renin concentration of HRS-7156
Pharmacodynamics (PD) endpoint of HRS-7156.
Measured: Day 1 - Day 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start12 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-7156 compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601087
- Sponsor's protocol ID
- HRS-7156-101
- Status last verified
- Aug 2026
- First submitted
- 15 May 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of HRS-7156 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07601087
- Acronym / sponsor ID
- HRS-7156-101
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 May 2026 (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.
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HRS-7156 compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| HRS-7156 | Experimental | Drug: HRS-7156 |
| HRS-7156 placebo | Placebo comparator | Drug: HRS-7156 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18 to 55 years old at informed consent signing;
- Male body weight ≥50 kg, female ≥45 kg; BMI 18.5 to 30 kg/m² at screening and baseline;
- Have no clinically significant abnormalities at screening and baseline;
- Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 1 week after the last dose (abstinence or highly effective contraception); no sperm/egg donation.
Key exclusion criteria (10 listed)
- A history or current severe diseases of multiple systems, or other diseases interfering with trial results;
- Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial;
- Blood donation/severe blood loss (≥400 mL) within 8 weeks, blood transfusion within 4 weeks before screening; planned blood donation during the trial;
- History of drug abuse/dependence; positive urine drug test at screening.Participation in other clinical trials within 3 months before screening or planned;
- participation during the trial; within 5 half-lives of a prior drug (whichever is longer);
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 |
|---|---|---|
| HRS-7156HRS-7156, specified dose on specified day. | Drug | HRS-7156 |
| HRS-7156 placeboHRS-7156 placebo, specified dose on specified day. | Drug | HRS-7156 placebo |
Primary outcome
Incidence of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to 14 days.
Safety: Incidence of adverse event (AE) and serious adverse event (SAE).
5 secondary outcomes
Area under the concentration time curve (AUC)
Time frame: Day 1 - Day 9.
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 - Day 9.
Time to maximum plasma concentration (Tmax)
Time frame: Day 1 - Day 9.
Renal clearance (CLR)
Time frame: Day 1 - Day 2.
Renin concentration of HRS-7156
Time frame: Day 1 - Day 9.
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-7156 in people with Heart Failure, run by Shandong Suncadia Medicine 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 10 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 24 Aug 2026. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Kaiyun Zhang (+86-0518-82342973, kaiyun.zhang.kz38@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event (AE) and serious adverse event (SAE) (time frame: Up to 14 days.). 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 24 Aug 2026.