NCT07232758 Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in Healthy Chinese Subjects After Single and Multiple Administration
| NCT ID | NCT07232758 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Chinese Healthy Adult Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-10-30 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2025-10-30 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07232758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Chinese Healthy Adult Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07232758 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07232758 currently recruiting?
Yes, NCT07232758 is actively recruiting participants. Contact the research team at yuanyuan.huang@hengrui.com for enrollment information.
Where is the NCT07232758 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07232758 clinical trial?
NCT07232758 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 42 participants.