Safety, Tolerability and Pharmacokinetic Study of HRS-8829

Beijing Suncadia Pharmaceuticals

Status and phase: Not yet enrolling; Phase 1

Conditions: Acute Ischemia Stroke

Treatments: Drug: HRS-8829;Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07083362

HRS-8829-101

Details and patient eligibility

About

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)

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 4 patient groups

Treatment group 1

Experimental group

Treatment:

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Treatment group 2

Experimental group

Treatment:

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Treatment group 3

Experimental group

Treatment:

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Treatment group 4

Experimental group

Treatment:

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo

Drug: HRS-8829;Placebo