New stroke drug candidate passes first safety check in healthy people
NCT ID NCT07083362
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety and tolerability of a new drug called HRS-8829 in 83 healthy adults aged 18 to 55. The drug is being developed for acute ischemic stroke. Participants received either the drug or a placebo, and researchers monitored side effects and how the drug moved through the body. The goal was to gather safety information, not to treat any disease.
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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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83 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Jan 2026
- 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 55 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. Male and female subjects aged 18 to 55 years old 2. The weight of female subjects was ≥45 kg, that of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-28.0 kg/m2 3. The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator. 4. Voluntarily participate in this clinical trial Exclusion Criteria: 1. Have any history of allergies 2. Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc 3. The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study 4. Those who test positive for any one of hepatitis B surface antigen, hepatitis C antibody, syphilis specific antibody or human immunodeficiency virus antigen-antibody during the screening period 5. Those whose screening period examination results are judged by the research doctor as abnormal and of clinical significance 6. Those who have used any drugs that inhibit or induce liver enzymes within one month before administration 7. Those who have used or are currently using any medication within two weeks prior to administration 8. Those who have received a vaccine within one month prior to screening (except for the influenza vaccine) or plan to receive a vaccine during the trial period 9. Those who have undergone major surgical operations within the six months prior to screening 10. Blood donation or loss of more than 400 mL within 3 months prior to screening 11. Participate in the clinical trial of the drug as a subject and take the trial drug 12. Consumed more than 14 units of alcohol per week on average within the 3 months prior to screening 13. Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day 14. Those who consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages daily 15. Consume special food within 48 hours before administration 16. Those with a history of drug abuse 17. Those who cannot tolerate venipuncture 18. Those who have special dietary requirements 19. The researchers believe that the subjects have any other factors that make them unsuitable for participating in this trial
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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.
Contacts and locations
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China