Actively Recruiting
Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-11-18
42
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study mainly evaluated the safety and tolerability, as well as the pharmacokinetic characteristics, of the injectable drug HRS-2183 after single and multiple administrations in healthy subjects.
CONDITIONS
Official Title
Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female subjects, aged 18 to 45 years
- Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m8)
- Agreement to use highly effective contraception during the study period and for a specified duration after the last dose
- Voluntarily provides written informed consent to participate in the study
You will not qualify if you...
- History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class
- History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.)
- Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests)
- Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening
- Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine)
- Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis)
- Use of any medication (including prescription, OTC, and herbal) within a specified period before the study
- Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions
- History of major surgery within the past 3 months or planned surgery during the study period
- Participation in another clinical trial within the past 3 months
- Significant blood loss, blood donation, or transfusion within the past 3 months
- History of excessive alcohol consumption or unwillingness to abstain during the study
- History of heavy smoking or unwillingness to abstain during the study
- History of drug abuse or positive drug screening test
- Inability to tolerate venous access or history of fainting during blood draws
- Inability to comply with the standardized diet provided during the study
- Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250100
Actively Recruiting
Research Team
Y
Yuanyuan Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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