Skip to main content
OpenTrials
Completed

NCT Number: NCT07083362

Safety, Tolerability and Pharmacokinetic Study of HRS-8829

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)

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

HRS-8829;Placebo

Drug

Subject will receive HRS-8829 at dose level 1.

Subject will receive placebo at dose level 1.

HRS-8829;Edaravone injection

Drug

Subject will receive HRS-8829 at dose level 2.

Subject will receive edaravone injection at dose level 5.

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: From ICF signing date to Day8 after single administration

  2. The incidence and severity of adverse events

    Time frame: From ICF signing date to Day15 after multiple administrations

  3. The Incidence and severity of adverse events

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 0 hour to 48 hour after single administration

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

    Time frame: 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

    Time frame: Day1 to Day15 after multiple administrations

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

    Time frame: Day1 to Day15 after multiple administrations

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

    Time frame: Day1 to Day15 after multiple administrations

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

    Time frame: Day1 to Day15 after multiple administrations

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

    Time frame: Day1 to Day15 after multiple administrations

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

    Time frame: 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

    Time frame: 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

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

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

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

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

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

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

    Time frame: 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

    Time frame: 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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.