Safety, Tolerability and Pharmacokinetic Study of HRS-8829

NCT ID: NCT07083362

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-11-30

Brief Summary

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

Conditions

Acute Ischemia Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment group 1

Group Type: EXPERIMENTAL

HRS-8829;Placebo

Intervention Type: DRUG

Subject will receive HRS-8829 at dose level 1.

Subject will receive placebo at dose level 1.

Treatment group 2

Group Type: EXPERIMENTAL

HRS-8829;Placebo

Intervention Type: DRUG

Subject will receive HRS-8829 at dose level 2.

Subject will receive placebo at dose level 2.

Treatment group 3

Group Type: EXPERIMENTAL

HRS-8829;Placebo

Intervention Type: DRUG

Subject will receive HRS-8829 at dose level 3.

Subject will receive placebo at dose level 3.

Treatment group 4

Group Type: EXPERIMENTAL

HRS-8829;Placebo

Intervention Type: DRUG

Subject will receive HRS-8829 at dose level 4.

Subject will receive placebo at dose level 4.

Interventions

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 1.

Subject will receive placebo at dose level 1.

Intervention Type: DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 2.

Subject will receive placebo at dose level 2.

Intervention Type: DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 3.

Subject will receive placebo at dose level 3.

Intervention Type: DRUG

HRS-8829;Placebo

Subject will receive HRS-8829 at dose level 4.

Subject will receive placebo at dose level 4.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Si Chen

Role: CONTACT

si.chen@hengrui.com

18896625886

Other Identifiers

HRS-8829-101

Identifier Type: -

Identifier Source: org_study_id