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NCT07083362CompletedPhase 1

Safety, Tolerability and Pharmacokinetic Study of HRS-8829

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

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

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)

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
83 (actual)
First submitted
16 Jul 2025
Start date
6 Aug 2025
Primary completion date
12 Jan 2026
Lead sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
Diseases
Stroke
NCT number
NCT07083362

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 83
  • From 6 Aug 2025 to the primary completion date, 12 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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
  • 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 with a history of drug abuse

Other

  • The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study
  • Those whose screening period examination results are judged by the research doctor as abnormal and of clinical significance
  • 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 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Anzhen Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.