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Acute Ischemia StrokePhase 1NCT07083362

Safety, Tolerability and Pharmacokinetic Study of HRS-8829

A Phase 1 study testing HRS-8829;Edaravone injection in people with Acute Ischemia Stroke, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction（DDI） Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Acute Ischemia Stroke
What is being tested?
HRS-8829;Edaravone injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
83 participants
Where
1 siteChina
Study dates
6 Aug 2025to 12 Jan 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Male and female subjects aged 18 to 55 years old
  • 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
  • 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.
  • Voluntarily participate in this clinical trial

Who cannot join

  • Have any history of allergies
  • 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
  • The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study
  • 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
  • Those whose screening period examination results are judged by the research doctor as abnormal and of clinical significance
  • Those who have used any drugs that inhibit or induce liver enzymes within one month before administration
Show all 19Show fewer
  • Those who have used or are currently using any medication within two weeks prior to administration
  • 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
  • Those who have undergone major surgical operations within the six months prior to screening
  • Blood donation or loss of more than 400 mL within 3 months prior to screening
  • Participate in the clinical trial of the drug as a subject and take the trial drug
  • Consumed more than 14 units of alcohol per week on average within the 3 months prior to screening
  • Those who smoked more than 5 cigarettes or an equivalent amount of tobacco per day
  • Those who consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages daily
  • Consume special food within 48 hours before administration
  • Those with a history of drug abuse
  • Those who cannot tolerate venipuncture
  • Those who have special dietary requirements
  • The researchers believe that the subjects have any other factors that make them unsuitable for participating in this trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: Safety, Tolerability and Pharmacokinetic Studies of Single and Multiple Administrations of HRS-8829 in Healthy Subjects

This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction（DDI）

Being tested
HRS-8829;Placebo, HRS-8829;Edaravone injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-8829;PlaceboDrug

    Subject will receive HRS-8829 at dose level 1.

    Subject will receive placebo at dose level 1.

  • HRS-8829;PlaceboDrug

    Subject will receive HRS-8829 at dose level 2.

    Subject will receive placebo at dose level 2.

  • HRS-8829;PlaceboDrug

    Subject will receive HRS-8829 at dose level 3.

    Subject will receive placebo at dose level 3.

  • HRS-8829;PlaceboDrug

    Subject will receive HRS-8829 at dose level 4.

    Subject will receive placebo at dose level 4.

  • HRS-8829;Edaravone injectionDrug

    Subject will receive HRS-8829 at dose level 2.

    Subject will receive edaravone injection at dose level 5.

Study groups in NCT07083362
Study groupRoleWhat they receive
Treatment group 1ExperimentalNot described
Receives: Drug: HRS-8829;Placebo
Treatment group 2ExperimentalNot described
Receives: Drug: HRS-8829;Placebo
Treatment group 3ExperimentalNot described
Receives: Drug: HRS-8829;Placebo
Treatment group 4ExperimentalNot described
Receives: Drug: HRS-8829;Placebo
Treatment group 5ExperimentalNot described
Receives: Drug: HRS-8829;Edaravone injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence and severity of adverse events

    Measured: From ICF signing date to Day8 after single administration

  2. The incidence and severity of adverse events

    Measured: From ICF signing date to Day15 after multiple administrations

  3. The Incidence and severity of adverse events

    Measured: from the date of ICF signing to the 21st day after DDI administration

Secondary outcomes (25)

  1. Maximum observed concentration of HRS-8829 and its metabolite in plasma (Cmax)

    Measured: 0 hour to 48 hour after single administration

  2. Area under the serum concentration time curve (AUC) of HRS-8829 and its metabolite in plasma

    Measured: 0 hour to 48 hour after single administration

  3. Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma

    Measured: 0 hour to 48 hour after single administration

  4. Half-life (T1/2) of HRS-8829 and its metabolite in plasma

    Measured: 0 hour to 48 hour after single administration

  5. Clearance (CL) of HRS-8829 and its metabolite in plasma

    Measured: 0 hour to 48 hour after single administration

  6. Volume of distribution (Vz) of HRS-8829 and its metabolite in plasma

    Measured: 0 hour to 48 hour after single administration

  7. Cumulative amount excreted (Ae0-t) of HRS-8829 and its metabolite in urine

    Measured: 0 hour to 48 hour after single administration

  8. Cumulative excretion fraction (Fe0-t) of HRS-8829 and its metabolite in urine

    Measured: 0 hour to 48 hour after single administration

  9. Renal clearance (CLr) of HRS-8829 and its metabolite in urine

    Measured: 0 hour to 48 hour after single administration

  10. Maximum observed concentration at steady-state of HRS-8829 and its metabolite in plasma (Cmax)

    Measured: Day1 to Day15 after multiple administrations

  11. Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolite in plasma

    Measured: Day1 to Day15 after multiple administrations

  12. Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolite in plasma

    Measured: Day1 to Day15 after multiple administrations

  13. Half-life (T1/2) of HRS-8829 and its metabolite in plasma

    Measured: Day1 to Day15 after multiple administrations

  14. Clearance (CL) of HRS-8829 and its metabolite in plasma

    Measured: Day1 to Day15 after multiple administrations

  15. Volume of distribution (Vz) of HRS-8829 and its metabolite in plasm

    Measured: Day1 to Day15 after multiple administrations

  16. Maximum observed concentration at steady-state of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day 16 after DDI study single-dose, plasma administrations

  17. Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study single-dose, plasma administrations

  18. Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study single-dose, plasma administrations

  19. Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study single-dose, plasma administrations

  20. Clearance (CL) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study single-dose, plasma administrations

  21. Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study single-dose, plasma administrations

  22. Area under the serum concentration time curve (AUC) at steady-state of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study multiple-dose, plasma administrations

  23. Time to maximum observed concentration (Tmax) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study multiple-dose, plasma administrations

  24. Half-life (T1/2) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study multiple-dose, plasma administrations

  25. Volume of distribution (Vz) of HRS-8829 and its metabolites M01 and edaravone

    Measured: Day1 to Day16 after DDI study multiple-dose, plasma administrations

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start6 Aug 2025
  3. Primary completion12 Jan 2026
  4. Study completion12 Jan 2026

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083362
Sponsor's protocol ID
HRS-8829-101
Status last verified
Jul 2025
First submitted
16 Jul 2025
Last updated
28 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRS-8829;Edaravone injection in people with Acute Ischemia Stroke, run by Beijing Suncadia 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: finished, as of the sponsor's last update on 28 Apr 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence and severity of adverse events (time frame: From ICF signing date to Day8 after single administration). 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?

On the ClinicalTrials.gov record for NCT07083362.

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 28 Apr 2026.

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