Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Chinese Healthy Adult Subjects

In brief

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.

Key facts

Study ID

NCT07232758

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

42

Starts

2025-10-30

Expected to finish

2026-02-01

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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