Heart FailurePhase 1NCT07551167
A Clinical Study of HRS-5765 in Healthy Participants
A Phase 1 study testing HRS-5765 Tablet in people with Heart Failure, run by Chengdu 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 (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- HRS-5765 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to Jan 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 18 to 65 years old at informed consent signing.
- Male body weight ≥ 50 kg and < 90.0 kg, female ≥ 45 kg and < 90.0 kg; BMI 19 to 26 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 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 3 months, 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.
Show all 10Show fewer
- 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
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Yang Lin, +86-010-64456045, linyang@anzhengcp.com
Shan Jing, +86-010-64456014, jingshan@anzhengcp.com
About this study
Official title: A Randomized, Double-Blind, Dose-Escalation, Placebo-Parallel Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HRS-5765 in Healthy Subjects, as Well as the Effect of Food on the Pharmacokinetics of HRS-5765 and the Effect of HRS-5765 on CYP3A4 Metabolic Enzymes
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of HRS-5765 in healthy participants.
- Conditions
- Heart Failure
- Being tested
- HRS-5765 Tablet, HRS-5765 Tablet 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-5765 TabletDrug
HRS-5765 tablet, specified dose on specified day.
HRS-5765 Tablet PlaceboDrug
HRS-5765 tablet placebo, specified dose on specified day.
| Study group | Role | What they receive |
|---|---|---|
| HRS-5765 group | Experimental | Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765. Receives: Drug: HRS-5765 Tablet |
| HRS-5765 placebo group | Placebo comparator | Participants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765 placebo. Receives: Drug: HRS-5765 Tablet Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE)
Safety parameter.
Measured: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Incidence of serious adverse event (SAE)
Safety parameter.
Measured: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Secondary outcomes (4)
Area under the concentration-time curve (AUC)
PK parameter of HRS-5765.
Measured: Day 1-Day 18.
Maximum plasma concentration (Cmax)
PK parameter of HRS-5765.
Measured: Day 1-Day 18.
Time to maximum plasma concentration (Tmax)
PK parameter of HRS-5765.
Measured: Day 1-Day 18.
Apparent clearance (CL/F)
PK parameter of HRS-5765.
Measured: Day 1-Day 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 May 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (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.
- 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-5765 compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551167
- Sponsor's protocol ID
- HRS-5765-101
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dose-Escalation, Placebo-Parallel Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HRS-5765 in Healthy Subjects, as Well as the Effect of Food on the Pharmacokinetics of HRS-5765 and the Effect of HRS-5765 on CYP3A4 Metabolic Enzymes
- ClinicalTrials.gov ID
- NCT07551167
- Acronym / sponsor ID
- HRS-5765-101
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Apr 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 (PK) and pharmacodynamics (PD) of HRS-5765 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-5765 compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| HRS-5765 group | Experimental | Drug: HRS-5765 TabletParticipants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765. |
| HRS-5765 placebo group | Placebo comparator | Drug: HRS-5765 Tablet PlaceboParticipants will be assigned to one of the planned dose cohorts and receive specified dose of HRS-5765 placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18 to 65 years old at informed consent signing.
- Male body weight ≥ 50 kg and < 90.0 kg, female ≥ 45 kg and < 90.0 kg; BMI 19 to 26 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 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 3 months, 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-5765 TabletHRS-5765 tablet, specified dose on specified day. | Drug | HRS-5765 group |
| HRS-5765 Tablet PlaceboHRS-5765 tablet placebo, specified dose on specified day. | Drug | HRS-5765 placebo group |
Primary outcome
Incidence of adverse event (AE)
Time frame: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Safety parameter.
Incidence of serious adverse event (SAE)
Time frame: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).
Safety parameter.
4 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: Day 1-Day 18.
Maximum plasma concentration (Cmax)
Time frame: Day 1-Day 18.
Time to maximum plasma concentration (Tmax)
Time frame: Day 1-Day 18.
Apparent clearance (CL/F)
Time frame: Day 1-Day 18.
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 26 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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-5765 Tablet in people with Heart Failure, run by Chengdu 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 26 May 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 Hui Xu (+86 0518-82342973, hui.xu.hx107@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) (time frame: Day 1-Day 7 (SAD period); Day 1-Day 14 (FE period); Day 1-Day 21 (MAD period).). The study lists 2 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 26 May 2026.