Overview
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.
Eligibility
Inclusion Criteria:
- 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/m²).
- Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation.
- Voluntarily provides written informed consent to participate in the study.
Exclusion Criteria:
- 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.