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

Hengrui Medicine

Status and phase: Enrolling; Phase 1

Conditions: Chinese Healthy Adult Subjects

Treatments: Drug: Placebo; Drug: HRS-2183

Study type: Interventional

Funder types: Industry

Identifiers

NCT07232758

HRS-2183-102

Details and patient eligibility

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects, aged 18 to 45 years.
2. Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²).
3. 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.
4. Voluntarily provides written informed consent to participate in the study.

Exclusion criteria

1. History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class.
2. History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.).
3. Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests).
4. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
5. Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine).
6. Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis).
7. Use of any medication (including prescription, OTC, and herbal) within a specified period before the study.
8. Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions.
9. History of major surgery within the past 3 months or planned surgery during the study period.
10. Participation in another clinical trial within the past 3 months.
11. Significant blood loss, blood donation, or transfusion within the past 3 months.
12. History of excessive alcohol consumption or unwillingness to abstain during the study.
13. History of heavy smoking or unwillingness to abstain during the study.
14. History of drug abuse or positive drug screening test.
15. Inability to tolerate venous access or history of fainting during blood draws.
16. Inability to comply with the standardized diet provided during the study.
17. Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Treatment group A:HRS-2183

Experimental group

Treatment:

Drug: HRS-2183

Treatment group B:placebo

Placebo Comparator group

Treatment:

Drug: Placebo