Safety, Tolerability and Pharmacokinetic Study of HRS-8829

NCT07083362 | Completed Phase 1

• 1 other identifier: HRS-8829-101
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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）

Conditions

Acute Ischemia Stroke

Outcome Measures

Primary Outcomes (3)

• The incidence and severity of adverse events

  From ICF signing date to Day8 after single administration

• The incidence and severity of adverse events

  From ICF signing date to Day15 after multiple administrations

• The Incidence and severity of adverse events

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

Secondary Outcomes (25)

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

  0 hour to 48 hour after single administration

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

  0 hour to 48 hour after single administration

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

  0 hour to 48 hour after single administration

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

  0 hour to 48 hour after single administration

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

  0 hour to 48 hour after single administration

Study Arms (5)

Treatment group 1

EXPERIMENTAL

Drug: HRS-8829;Placebo

Treatment group 2

EXPERIMENTAL

Drug: HRS-8829;Placebo

Treatment group 3

EXPERIMENTAL

Drug: HRS-8829;Placebo

Treatment group 4

EXPERIMENTAL

Drug: HRS-8829;Placebo

Treatment group 5

EXPERIMENTAL

Drug: HRS-8829;Edaravone injection

Interventions

HRS-8829;Placebo DRUG

Subject will receive HRS-8829 at dose level 1. Subject will receive placebo at dose level 1.

Treatment group 1

HRS-8829;Edaravone injection DRUG

Subject will receive HRS-8829 at dose level 2. Subject will receive edaravone injection at dose level 5.

Treatment group 5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: August 6, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-07

Locations

CN (1)