New heart drug HRS-5765 takes first step in human safety trial
NCT ID NCT07551167
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of a new oral drug called HRS-5765, which may one day treat heart failure. About 74 healthy adults aged 18-65 will receive single or multiple doses to see how the drug moves through the body and if it causes side effects. No direct treatment benefit is expected for participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy men and women aged 18 to 65 years old at informed consent signing. 2. 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. 3. Have no clinically significant abnormalities at screening and baseline. 4. 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. Exclusion Criteria: 1. A history or current severe diseases of multiple systems, or other diseases interfering with trial results. 2. Severe infection, trauma, major surgery within 3 months before screening; Planned surgery during the trial. 3. Blood donation/severe blood loss (≥ 400 mL) within 3 months, blood transfusion within 4 weeks before screening; Planned blood donation during the trial. 4. History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned. 5. Participation during the trial; Within 5 half-lives of a prior drug (whichever is longer). 6. Smoking history (≥ 5 cigarettes/day) within 4 weeks before screening; Inability to abstain from tobacco during the trial. 7. Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening. 8. Special dietary requirements and inability to comply with the unified diet. 9. Difficulty in swallowing/venous blood collection; Intolerance to intensive blood sampling. 10. Other circumstances deemed unsuitable for trial participation by researcher.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Anzhen Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100029, China
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Other studies related to the condition(s) this trial covers.
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- Can better training get doctors to talk about what matters most to dying veterans?