Status:
NOT_YET_RECRUITING
A Single Ascending Dose of HRS-4029 in Healthy Subjects
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.
Eligibility Criteria
Inclusion
- Age between 18 to 55 years.
- Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
- Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.
- Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Exclusion
- Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.
- Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .
- Subjects with positive tests for infectious diseases.
- Female who are pregnant or breastfeeding.
- Unable to tolerate venipunctures or have a history of fainting needles and blood.
- Historic abuse of alcoholic beverages
- Smoke ≥5 cigarettes per day within 3 months prior to the study
- History of drug abuse.
- Other reasons that the investigator consider it inappropriate to participate in the trial.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06905314
Start Date
April 1 2025
End Date
December 1 2025
Last Update
April 1 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029