Safety and drug-level testing of HRS-2183 injection in healthy Chinese adults after single and multiple doses

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

This will test whether single and repeated injections of HRS-2183 are safe and how the drug is processed in healthy Chinese adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07232758 on ClinicalTrials.gov

What this trial studies

This phase 1 interventional study gives healthy Chinese adults single and multiple doses of HRS-2183 or placebo to characterize safety, tolerability, and pharmacokinetics. Participants undergo regular safety monitoring, vital signs, laboratory tests, and blood sampling to measure drug levels over time. Eligibility is limited to men and women aged 18–45 with specified weight and BMI ranges and contraception requirements for the study period. The sponsor is Jiangsu HengRui Medicine Co., Ltd., and the study is conducted at Qilu Hospital of Shandong University in Jinan.

Who should consider this trial

Good fit: Healthy Chinese adults aged 18–45 with body weight and BMI within the specified range who agree to contraception and study procedures are ideal candidates.

Not a fit: People with significant allergies, chronic medical conditions, abnormal screening tests, ECG abnormalities, pregnant or planning pregnancy, or those outside the age/BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, results could show HRS-2183 is well tolerated and provide dosing and safety data needed for later patient studies.

How similar studies have performed: Early-phase safety and pharmacokinetic studies like this are a standard first step and have helped guide dosing for many drugs, though they do not demonstrate clinical benefit.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

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

Study contacts

• Study coordinator: Yuanyuan Huang

Conditions Chinese Healthy Adult Subjects